Model Number N/A |
Device Problems
Difficult to Insert (1316); Device-Device Incompatibility (2919)
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Patient Problem
No Information (3190)
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Event Date 08/31/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Multiple mdr¿s were submitted for this event.Please see reports: 0002648920-2017-00597.(b)(4).Report source foreign.The event occurred in (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.
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Event Description
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It was reported that during the procedure the implant would not assemble properly.A different implant was used to complete the procedure.A surgical delay of 10 minutes was reported.No additional patient consequences were reported.No further information is available at this time.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.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 as the necessary information to adequately investigate the reported event was not provided.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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(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.Complaint sample was evaluated and the reported event was confirmed.Visual inspection identified that the liner was inserted into the shell and was severely damaged.The locking ring tab appeared to be in the correct position.Dimensional analysis could not be performed as damage was too severe.No other anomalies were noted.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 report 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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