Model Number N/A |
Device Problem
Unstable (1667)
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Patient Problem
Failure of Implant (1924)
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Event Date 02/22/2022 |
Event Type
Injury
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Event Description
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It was reported that patient underwent a left knee revision approximately a year post implantation due to instability.
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Manufacturer Narrative
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(b)(4).Concomitant medical products: medical devices: oss poly tibial bushing catalog#: 150476 lot#: 468770.Oss poly femoral bushings 2pk catalog#: 150477 lot#:161900.Oss axle catalog#: 150480 lot#: 902130.Oss reinforced yoke catalog#: 150493 lot#: 170530.Oss poly bumper lock pin catalog#: 150510 lot#: 451760.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was retained by the hospital.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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No further event information available at the time of this report.
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Manufacturer Narrative
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Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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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