(b)(4).Concomitant medical products ¿ oxford anatomic bearing size 8 catalog 159580 lot 1195337; oxford tibial tray size d catalog 154725 lot 1278419.Customer has not indicated whether product will be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2017-00543, 3002806535-2017-00542.
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It was reported a patient underwent a revision procedure to convert from a right partial knee prosthesis to a total knee approximately seven years post implantation due to pain, wear, instability, and arthroplasty collapse with migration.The patient reportedly began experiencing pain and instability approximately three and a half years post-operatively, however no issues were found until the patient began experiencing worsening pain approximately seven years post-operatively.The femoral and tibial components were said to have been in contact with one another and were noted to have evidence of gross abrasive wear.The tibial bearing was also noted to evidence asymmetrical wear.
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