Model Number N/A |
Device Problem
Naturally Worn (2988)
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Patient Problem
No Code Available (3191)
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Event Date 01/22/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Implant date - the product was implanted on an unknown date in 1996.Concomitant medical products- unknown orthopedic salvage system femoral component catalog #: ni lot #: ni, unknown orthopedic salvage system tibial component catalog #: ni lot #: ni.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the hospital would not release the product.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Investigation incomplete.
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Event Description
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It is reported that the patient underwent a knee arthroplasty revision to exchange the polyethylene bearing to address wear approximately twenty (20) years post-operatively.No additional patient consequences were reported.
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Event Description
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No further event information available at the time of this report.
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Event Description
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No further event information available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The product was evaluated through photographic inspection of explanted device.The tibial bearing showed signs of wear and potential delamination.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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