Fig. \u00a01 and 2<\/u><\/em><\/strong> \u2013 Analyze of the case from \u00a0[2<\/em>]<\/em><\/p>\n However, this bone substitute cracked after 6 months. The reason was a defective internal structure after printing, incorrect geometry, and high stress. The implant is loaded with low-cyclic fatigue, and considering the above, the substitute did not last. This can happen, even if it should not, but what about compensation for damage?<\/p>\n If it happens on a machine, the part is simply replaced, and you move on. Any claims for defective performance or compensation for damages are handled through the Civil Code using standard processes. But what if it happens to a person?<\/p>\n The patient not only has to be in terrible pain but is also bedridden and immobile again. And a possible re-operation for a new implant brings additional risks, because its location is already affected by the installation of the first implant.<\/p>\n I found out that this is not an unknown topic at all, and many comments can be found on the Internet.<\/p>\n For example, here [2] you can find a view from the USA. The National Library of Medicine has published an analysis of the state of 3D printing with the aim of defining the legal framework for 3D printing for medical purposes. It follows that the principle of fault must be examined throughout the chain, from the powder manufacturer, the printer, to the surgeon who performs the operation.<\/p>\n Fig. 3<\/u><\/em><\/strong> \u2013 View of responsibility in the USA according to source [2]<\/em><\/p>\n The Czech model is seemingly simpler, it does not examine either the source powder for printing or the printer, however, it is considered that both fall within the competence of the printing contractor with all necessary links. Thus, there must be a clear procedure for purchasing, periodic validation of printers, HIP, vacuum ovens and other equipment must be carried out according to the relevant standards and regulations, generally covered by MedAccred<\/strong> certification, ISO 13485<\/strong>, etc.<\/p>\n The division of responsibility between the patient, hospital and implant manufacturer is subject to both civil liability (in particular under the Civil Code and the Health Services Act), and potentially also liability for a defective product under Act No. 89\/2012<\/strong> Coll. (Civil Code) and Act No. 22\/1997<\/strong> Coll. on technical requirements for products.<\/p>\n Implant manufacturer \u2013 liability for defective product<\/strong><\/p>\n The implant ruptured due to:<\/strong><\/p>\n Conclusion<\/strong>: The manufacturer bears primary liability for a defective product, especially if it could be proven that the technology used was inadequate and standard (e.g. no HIP or heat treatment) \u2013 which is commonly required for Ti6Al4V in medicine.<\/p>\n Generally, the warranty period for hidden defects is 2 years, but in the case of patient damage it is 10 years. According to EU 2024\/2853 – The limitation period for a claim for compensation for damage caused by a defective product is 10 years from the placing of the product on the market. However, if the injured party could not initiate proceedings within ten years from the dates referred to in paragraph 1 due to the latency of the personal injury, he will lose the right to compensation under this Directive after the expiry of a period of 25 years.<\/p>\n Hospital \u2013 liability for product selection and use<\/strong><\/p>\n The hospital (or the treating physician) could be held jointly liable if:<\/p>\n Conclusion:<\/u><\/strong> If the hospital selected this implant without checking its certification, approval, quality, and without fully informing the patient, it may bear partial responsibility.<\/p>\n Of course, the patient may also bear some responsibility if he actively violated the treatment regimen.<\/p>\n But there is another circumstance. The hospital prepares the data, the STL<\/strong> file for 3D printing<\/strong>. From the point of view of responsibility and compliance with the MDR<\/strong> and civil law principles, it is therefore necessary to carefully distinguish between the role of the hospital as a “designer”<\/strong> and the manufacturer as a implementer of the device<\/strong>.<\/p>\n The hospital \/ doctor (supplier of the data, the design – STL file<\/strong>), provides the source data for the construction of the implant (from CT \/ MRI<\/strong>), and fundamentally influences the shape, thickness, geometry, and therefore the biomechanical properties, e.g. stress concentration.<\/p>\n If the strength check of the design is not performed (e.g. FEA – Finite Element Analysis<\/strong>), the design may be unsuitable from the beginning. The MDR<\/strong> explicitly states that if a medical institution designs a device, it becomes a (co)manufacturer and is subject to similar obligations. MDR<\/strong> (Medical Devices Regulation<\/strong>) – Regulation (EU) 2017\/745<\/strong>.<\/p>\n It follows that the hospital may be jointly liable for a design error if it prepares the STL<\/strong> file and this leads to a faulty stress distribution \u2192 subsequent mechanical failure of the implant.<\/p>\n And what does the MDR<\/strong> say about custom-made medical devices? According to Article 2(3) of the MDR<\/strong>: \u201cCustom-made medical device\u201d means a device designed on the basis of a written prescription from a qualified professional (e.g. a doctor) who:<\/p>\n Such devices are not subject to certification by a notified body, but the manufacturer must comply with certain obligations, in particular under Article 10(9) and Article 22 of the MDR<\/strong>.<\/p>\n The implant manufacturer must meet the following:<\/strong><\/p>\n a) Must have a quality management system (QMS<\/strong>), and must be able to:<\/p>\n b) There must also be technical documentation (Annex XIII MDR<\/strong>). For custom-made implants, the so-called simplified technical documentation is sufficient, but it must exist for each product (e.g. description of the design, material, manufacturing method, quality control method, etc.).<\/p>\n c) Manufacturer’s declaration (Declaration<\/strong>)<\/p>\n Each implant must be accompanied by a declaration that:<\/p>\n Since implants are individual customer products, it is not possible to validate individual pieces, but the manufacturing process.<\/p>\n This means that the manufacturer does not have to validate each specific shape, but must demonstrate that the entire production chain can repeatedly and safely produce devices that meet the MDR requirements, i.e. reliably and reproducibly.<\/p>\n To meet this, it must also be the owner of a manufacturing permit for custom-made implants, i.e. it must be registered as a manufacturer of medical devices with S\u00daKL <\/strong>(in the Czech Republic),<\/p>\n If a medical device designs a device, it becomes a (co)manufacturer and is subject to similar obligations. It influences the design of the implant, and therefore its geometry, strength criteria, etc. It is therefore jointly responsible for an error in the design if it prepares the STL <\/strong>file and this leads to a faulty stress distribution \u2192 subsequent mechanical failure of the implant.<\/p>\n The same applies here as with heat treatment,<\/p>\n \u00a7 2594<\/strong><\/p>\n (1) The contractor shall notify the client without undue delay of the unsuitable nature of the item that the client has handed over to him for the performance of the work, or of the order that the client has given him. This does not apply if he could not detect the unsuitableness even after exercising due care.<\/p>\n The implant manufacturer therefore manufactures a medical device to order based on the STL file supplied by the hospital,<\/p>\n The implant manufacturer is therefore responsible for the process, but if he prints an unvalidated or unsuitable STL<\/strong> design without retrospective control, he may also share responsibility for the design.<\/p>\n If a hospital designs an individual implant and has it manufactured externally, it can also be considered a manufacturer under the MDR<\/strong>, or at least a “designer” with responsibility for the design.<\/p>\n The responsibility of the one who prints and the one who submits the design is therefore shared, but in a specific case, expert opinion (e.g. biomechanics + metallurgy) will decide.<\/p>\n Contractual relationship<\/strong><\/p>\n The patient absolutely has no contractual relationship with the implant manufacturer. However, there is a contractual relationship, even if a contract has not been signed, between the patient and the hospital in the form of a so-called implicit contractual relationship according to Section 2636 <\/strong>et seq. of the Civil Code (NOZ):<\/p>\n Health services are provided on the basis of a “health care contract”, which is created by the patient’s admission for treatment. The patient therefore automatically has a contractual relationship with the hospital, which is responsible for the selection of the treatment procedure, the means used and informing the patient. If the hospital has chosen an unsuitable design or implant, it can be sued for breach of contractual obligation (Section 2913<\/strong> NOZ).<\/p>\n Primarily, the patient can sue the hospital, because he has a contractual relationship with it. However, this does not prevent the assertion of a claim against the implant manufacturer, compensation for damage caused by a defective product according to Section 2939<\/strong> et seq. of the NOZ (defective product), or according to Act No. 22\/1997<\/strong> Coll. on technical requirements for products, or according to Act No. 378\/2007<\/strong> Coll. (Act on Pharmaceuticals and Medical Devices).<\/p>\n In this case, however, the patient is obliged to prove that the product was defective and caused damage (e.g. by an expert opinion).<\/p>\n The patient therefore has two options. File a lawsuit against the hospital with which he has a contractual relationship, and if compensation for damage is awarded, the hospital can then claim reimbursement from the manufacturer.<\/p>\n Sue the hospital separately and the implant manufacturer separately. In this case, the lawsuit must be carefully constructed to describe the share of guilt of both entities, and at the same time there is evidence that the design and production contributed to the failure, and the patient wants to maximize the chance of successfully recovering compensation.<\/p>\n Patient<\/strong><\/p>\n The patient bears the burden of proof. However, he is bedridden, in pain, without legal knowledge, often without the ability to communicate properly, has no professional knowledge and does not have access to his medical documentation. The patient is therefore in a very difficult position. This is a well-known problem throughout the EU, and that is why some courts (including Czech courts) have begun to mitigate or shift part of the burden of proof to the care provider in similar cases \u2013 especially when it comes to:<\/p>\n However, without an expert (ideally a biomechanic, orthopedist, materials engineer), it is almost impossible to win a court case. The expert must prove:<\/p>\n In this case, the hospital is obliged under Act 372\/2011<\/strong> Coll. provide a copy of the patient’s medical documentation (upon request), documentation on the implant (e.g. type, production report) can also be requested, and the manufacturer may be asked by the court to submit technical documentation – if sued.<\/p>\n It is therefore worth contacting an experienced lawyer in medical law – because the legal strategy (e.g. choice of defendant, evidentiary proposal, proposal for an expert opinion) is key.<\/p>\n So much for the paragraphs. If I look at it from the perspective of the manufacturer, the one who prints the implants, he should follow the instructions of the customer, i.e. work with the STL file<\/strong> sent by the medical facility or contradict it.<\/p>\n But if he accepts it, he must proceed according to the usual procedures<\/strong>. What does this mean? The current level of knowledge says that a 3D printed product<\/strong> exhibits porosity. This can be a source of future failure. There is only one technology that can correct this defect, and that is HIP<\/strong>. If, contrary to this knowledge, the manufacturer does not apply HIP to eliminate hidden defects, he is exposed to the risk<\/strong> of being penalized in the event of implant failure and proceedings for damages. Just as in the aviation industry, critical parts made of precision casting must undergo HIP for the safety of pilots and passengers, so too must HIP<\/strong> be applied to 3D printing<\/strong> of implants.<\/p>\n If this case arose and I were asked for an expert opinion, this would be the first thing I would investigate.<\/p>\n <\/p>\n![\"\"](\"https:\/\/intelligent-kalam.80-240-27-133.plesk.page\/wp-content\/uploads\/2025\/06\/369-obrazek1.png\")
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