Model Number N/A |
Device Problem
Unstable (1667)
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Patient Problems
Adhesion(s) (1695); Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671)
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Event Date 01/14/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The customer has indicated that the product will not be returned to zimmer biomet for investigation as it was discarded.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: 0001825034-2021-00317.
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Event Description
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It was reported that the patient underwent a right total knee arthroplasty.A year post implantation, the patient underwent separate revisions of the patellar implant and tibial bearing.Approximately 6 years later, the patient underwent a poly exchange due to aseptic loosening following a fracture of the poly bearing post.The patient then underwent a fourth revision due to fracture of the poly bearing post and instability approximately 5 years later.During the revision, extensive scar tissue was removed, and a new femoral component and bearing was placed without complication.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Upon receiving additional information of the reported event, this device was determined to be not reportable.The initial report should be voided.
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Event Description
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Upon receiving additional information of the reported event, this device was determined to be not reportable.The initial report should be voided.
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Search Alerts/Recalls
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