Model Number N/A |
Device Problem
Inadequacy of Device Shape and/or Size (1583)
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Patient Problem
Unequal Limb Length (4534)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).The device will not be returned for analysis remains implanted; 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: 0001825034 - 2021 - 01398.
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Event Description
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It was reported by pmi group that a custom hip needed for revision on unknown date.The surgeon wants to add an adapter to the current hip implant to correct the leg length discrepancy.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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Once the investigation is completed, a supplemental mdr will be submitted.
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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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Event Description
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No further event information 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 evaluations could not be performed.Lot identification is necessary for review of device history records, lot identification was not provided.Medical records were not provided.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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Search Alerts/Recalls
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