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Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
Insufficient Information (4580)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Product remains implanted and will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2024-00332; 0001822565-2024-00333; 0001822565-2024-00335.
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Event Description
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It was reported that the patient underwent a hip arthroplasty on an unknown date.Subsequently, the patient was being considered for a revision for an unknown reason; however, it was determined on an unknown date that the patient did not end up needing or having a revision.No additional information available.
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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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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 evaluation could not be performed.Radiographs were provided and reviewed by a health care professional.A review of the available records identified the following: right total hip arthroplasty with oversized acetabular cup and shallow acetabular inclination angle.Part and lot identification are necessary for review of device history records and compatibility checks, and neither were provided.Additionally, no problem was found with the devices upon further follow up.It was reported that the implant identification was not related to a revision and was just a follow up visit with a new patient.Additionally, the size and placement of the acetabular components are to the surgeon's discretion and does not indicate an implant issue.This complaint could not be confirmed.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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Search Alerts/Recalls
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