Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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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).D10: unknown head.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.
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Event Description
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It was reported that the patient has been indicated for a revision due to unknown reasons.No revision has been reported to date.Attempts to obtain additional information have been made; however, no more information is available at this time.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: b4; b5; g3; h2; h6.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2024-01440.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: right hip arthroplasty dislocation.Regional osteolysis.This complaint cannot be confirmed.It is unknown why the patient was being considered for a revision.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event 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 additional event information to report at this time.
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Search Alerts/Recalls
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