All product features corresponded with the valid specifications of the waldemar link (b)(4) at the time period, when the product was delivered to the customer.The cause of premature wear of the tibial pe plain bearing with delamination at the left knee joint cannot be determined with the data available to us.Without knowing the patient-specific and intraoperative necessities, it was possible to the joint more than normal.Ultimately, the final decision in favour of an implant from the surgeon, based on his individual analysis and experience for each patient.The examination of the complaint sample did not reveal any evidence of a material or manufacturing defects causing the damage.The report is delayed due to inconsistencies with regard to foreign event reporting to fda.After re-evaluation of the complaint we determined that it is reportable.We have addressed the inconsistency in reporting foreign events to fda through capa-(b)(4).
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Translation: patient satisfied after sled prosthesis implantation.On (b)(6) 2015 an arthroscopy of the knee joint was performed due to an external meniscus lesion.The rough delamination of the pe inlay of the medial tibial sled prosthesis, which led to the surgical revision and sled explantation on (b)(6) 2015, was revealed.
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