Catalog Number 183442 |
Device Problem
Material Erosion (1214)
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Patient Problem
Joint Laxity (4526)
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Event Date 04/02/2024 |
Event Type
Injury
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Event Description
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It was reported that a patient underwent an initial total knee arthroplasty on an unknown date.Subsequently, on an unknown timeframe post-implantation, the patient began to experience instability and underwent revision surgery due to wear of the articular surface.Due diligence is in progress for this event; to date no further information has been reported.
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Manufacturer Narrative
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(b)(4).D10: medical product: unknown tibial component: catalog#ni, lot#ni; unknown femoral component: catalog#ni, lot#ni.G2: foreign: australia.The product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections have been updated: a1; a2; a3; b4; b5; b7; d6a; d10; g3; h2; h6; h11.D10: medical product: unknown vanguard cr femoral component 70mm: catalog#ni, lot#ni; unknown 75mm regenerex tibial tray: catalog#ni, lot#ni.The investigation is in process.Upon completion of the investigation, a follow-up mdr will be submitted.
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Event Description
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It was reported that a patient underwent an initial total knee arthroplasty.Subsequently, approximately eight (8) years post-implantation, the patient began to experience instability and underwent revision surgery due to wear of the articular surface.Due diligence is complete as multiple attempts have been made; all available information has been reported.
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Search Alerts/Recalls
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