Model Number N/A |
Device Problem
Positioning Failure (1158)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/10/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Concomitant medical products: 010000664 ¿ g7 shell ¿ 6559711.00625006535 ¿ bone screw - j6838814.Customer has indicated that the product will not be returned to zimmer biomet as the product remains implanted at this time.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2021 - 00917.
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Event Description
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It was reported that during a left hip procedure, the screw went through the shell completely.The screw remains implanted and there was no reported harm or injury to the patient.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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This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information provided by the customer.Dhr was reviewed and no discrepancies were found.The root cause is unable to 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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