Model Number N/A |
Device Problem
Difficult to Remove (1528)
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Patient Problem
No Information (3190)
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Event Date 10/16/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Foreign: country: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported from (b)(6) faced this problem during the bipolar thr, it was noticed that after doing a trial reduction on original wagner cone implant the surgeon faced difficulties to remove the trial as it gets locked badly.This issue he has faced many times.The surgeon stated that after removing the trial he sees abrasions inside the trial.No additional information.
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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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Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was 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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Manufacturer Narrative
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Upon reassessment of the reported event, the event was determined to be not reportable.The initial report was forwarded in error and should be voided.
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Event Description
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Upon reassessment of the reported event, the event was determined to be not reportable.The initial report was forwarded in error and should be voided.
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Search Alerts/Recalls
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