Model Number N/A |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Damage to Ligament(s) (1952); Joint Dislocation (2374)
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Event Date 01/26/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Report source: foreign - australia.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: 0001822565-2023-00384.
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Event Description
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It was reported that the patient was revised approximately 2.5 years post implantation due to dislocation while getting up from a chair.It was noted that the extensor mechanism was compromised.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.H6: proposed component (annex g) code is mechanical (g04) - femur.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.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: dislocation of the implant, no signs of loosening wear, radiolucency, or other contributing factors.A definitive root cause cannot be determined.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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