Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
Insufficient Information (4580)
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Event Date 04/10/2024 |
Event Type
Injury
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Event Description
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It was reported the patient underwent an initial hip arthroplasty on an unknown date.Subsequently, the patient was revised for an unknown reason.The continuum cup and liner were replaced with g7 dual mobility.
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Manufacturer Narrative
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(b)(4).D10: unknown continuum cup unknown.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.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional and/or corrected information.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided for both the continuum cup and the liner.Complaint history review cannot be performed without product identification.Medical records were not provided.A definitive root cause cannot be determined.This complaint cannot be confirmed.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 additional event information to report at this time.
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Search Alerts/Recalls
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