Model Number N/A |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problems
Ossification (1428); Unspecified Infection (1930); Local Reaction (2035); Osteopenia/ Osteoporosis (2651); Metal Related Pathology (4530); Swelling/ Edema (4577)
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Event Date 01/12/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: unknown item # - bearing - 823990.Unknown item # - femoral component - 226960.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-00250, 0001825034-2022-00251.
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Event Description
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It was reported that the patient underwent a knee revision approximately 17 years post implantation due to poly wear and metallosis.It was noted that the knee was infected.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.The root cause for infection per nursing review was found to be non-device related.A definitive root cause cannot be determined for metallosis, pain and wear.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 available at the time of this report.
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Search Alerts/Recalls
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