(b)(4).D10 medical devices: nexgen femoral component precoat size d left catalog#: 00595001401, lot#: 62507708.Nexgen articular surface size yellow/c-h 10 mm height catalog#: 00595203010, lot#: 62815614.Nexgen all poly patella standard size 35 mm diameter 9.0 mm catalog#: 00597206635, lot#: 62928274.Stryker bone cement part#: ni, lot#: ni.Stryker bone cement part#: ni, lot#: ni.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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It was reported that patient underwent a left total knee arthroplasty.Patient reported pain, swelling, and instability since the initial procedure.Approximately nine years post-implantation, the patient underwent an aspiration procedure to check for infection and then an ultrasound to check for blood clots.A ten degree malformation was noted during the ultrasound.No further intervention has been reported.
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