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Model Number N/A |
Device Problem
Migration (4003)
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Patient Problems
Pain (1994); Osteolysis (2377); Metal Related Pathology (4530)
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Event Date 03/02/2024 |
Event Type
Injury
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Event Description
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It was reported that a patient underwent a right knee revision approximately eleven years post-implantation due to pain, metallosis, and disassociation of the femoral stem from the distal femoral implant.
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2024-01000, 0001822565-2024-01001, and 0002648920-2024-00083.D10 medical devices: rotating hinge knee right size e cemented option femoral component catalog#: 00588001502 lot#: 62080614.Nexgen 14mm diameter 100mm length straight stem extension catalog#: 00598801014 lot#: 61748147.14mm height size e articular surface with hinge post extension catalog#: 00588005014 lot#: 62366280.Unknown rhk tibial tray catalog#: ni lot#: ni.Prc agmt block post sz e 10mm catalog#: 00599003502 lot#: 61405568.Prc agmt block post sz e 10mm catalog#: 00599003502 lot#: 62417507.Prc agmt block dist sz e 10mm catalog#: 00599003520 lot#: 61529985.Prc agmt block dist sz e 10mm catalog#: 00599003520 lot#: 61601937.G2 foreign source: australia.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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Event Description
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It was reported that patient underwent a right knee procedure.Subsequently, approximately eleven years later, the patient returned to surgery due to pain with the intention of exchanging the tibial insert.During the revision, metallosis and disassociation of the femoral stem from the distal femoral implant was noted.At the time of surgery, implants for a full revision were not available, so a new tibial insert was placed, the incision was closed, and the patient returned four days later for a revison of the femoral components.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.
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Search Alerts/Recalls
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