(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001825034-2024-00271; 0001825034-2024-00272; 0001825034-2024-00273.D10-medical product vanguard cr ilok fem-rt 65 item# 183008 lot# j6917396 series a pat std 25 3 peg item# 184760 lot# 807800 biomet cc cruciate tray 71mm item# 141233 lot# j6869986 bone screw self-tapping 6.5 mm dia.25 mm length item# 0062500652lot# 64611734 qty: (b)(4) biomet bc r 1x40 us item# 110035368 lot# f2701z12ba qty: (b)(4).H3- customer has indicated that the product will not 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.
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It was reported that a patient was revised approximately two years and four months post implantation due to pain, instability, effusions, and patella impingement with malalignment.Attempts to obtain additional information have been made; however, no more information is available.
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