It was reported that, on literature review: ¿arthroscopic mosaicplasty: long-term outcome and joint degeneration progression¿, 3 patients had failed grafts after surgery with an autogenous osteochondral grafting system.The complications were treated with a revision autologous chondrocyte transplantation.No further information is available.
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H10: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.No product identification information was provided and thus a product history review, complaint history review, instructions for use review, and risk management review could not be conducted.The data presented in the aged article does not provide insight or relevance to current clinical outcomes for the product/device.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be performed.Therefore, no further medical assessment is warranted at this time.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
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