Model Number N/A |
Device Problem
Separation Failure (2547)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/28/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device will not be returned for analysis due to the location of the device is unknown; 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 report: 0001822565-2020-03502.
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Event Description
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It was reported the trial head ball would not disengage from avenir complete stem during initial total hip arthroplasty.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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No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Part and lot identification are necessary for review of device history records, neither were provided for the trial.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 available at the time of this report.
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Search Alerts/Recalls
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