Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problems
Pain (1994); Loss of Range of Motion (2032)
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Event Date 03/22/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-01634 and 0001822565-2021-01635.Report source foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was requested from the hospital but not returned.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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It was reported that patient underwent a right knee revision approximately six years post-implantation due to pain, instability, and implant fracture.Attempts to obtain additional information have been made; however, no more is available at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of photograph and x-rays.Visual examination of the provided pictures identified a fractured articular surface.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: broken hinge post with secondary malalignment; no osseous fracture; serve polyethylene wear with metal on metal contact; implant fit maintained; bone quality appears osteopenic.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.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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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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