Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
Insufficient Information (4580)
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Event Date 01/11/2024 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.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: 0001825034-2024-00142, 0001825034-2024-00126.
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Event Description
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It was reported that approximately 30 years post implantation of a left primary hip, the patient was revised for an unknown reason.No additional information was available.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.H6: component code: mechanical (g04) ¿ stem.No product was returned, or pictures provided; visual and dimensional evaluation could not be performed.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues: impressions: eccentric position of the femoral head of the left hip arthroplasty reflecting advanced liner wear.Minimal osteolysis without implant loosening.Osteopenia.Part and lot identification are necessary for review of device history records and compatibility checks, and neither were provided.The reported issue cannot be confirmed as the reason for revision is unknown.A definitive root cause cannot be determined.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 is available at the time of this report.
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Search Alerts/Recalls
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