Model Number N/A |
Device Problems
Inadequacy of Device Shape and/or Size (1583); Insufficient Information (3190)
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Patient Problem
Insufficient Information (4580)
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Event Date 07/01/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: unknown femoral component.Unknown tibial tray.Report source: foreign country: germany.Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the location of the device is unknown.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: 0001822565 - 2022 - 02246, 0001822565 - 2022 - 02247.
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Event Description
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It was reported the patient underwent initial knee arthroplasty on unknown date.Subsequently, the patient was revised due to unknown reason.Attempts have been made and additional information on the reported event is unavailable at this time.
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Event Description
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No further event information at 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.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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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: b4; b5; g3; h2; h6; h10.Previous investigation results have not changed upon review of additional information provided.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No further event information at 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 following sections have been updated: b4; b5; g3; h2; h6; h10.The additional information received has prompted a review of the previous investigation.The investigation is in progress.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, on an unknown timeframe post-implantation, the patient underwent revision surgery to exchange the articular surface as it was noted that the originally implanted articular surface was the incorrect size for the patient.Due diligence is complete as multiple attempts have been made; it was reported that no further information is available.
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Search Alerts/Recalls
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