Model Number N/A |
Device Problems
Corroded (1131); Difficult to Remove (1528)
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Patient Problem
Reaction (2414)
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Event Date 04/06/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).It is unknown if product is being returned to zimmer biomet for investigation, as its location is unknown; however, an investigation has been initiated.Once the investigation has been completed, a follow- up mdr will be submitted.
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Event Description
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Medical records received indicate difficulty removing the femoral head, which resulted in a delay of one hour.Operative report indicates the head was removed with a burr and black corrosion on the taper adapter and trunionosis were present within the joint.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of operative notes.Device history record was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no trends were identified.A definitive root cause could not be determined with information available.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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This follow-up report is being submitted to relay additional information.
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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 confirmed by review of medical records and evaluation of complaint sample.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.M2a magnum tpr adpr ti dia42-5 0/0mmt1 item# 139256 lot# 747300 was returned and evaluated.Upon visual inspection the device had damage to the taper location and the outer shell.There was some visible discoloration to the inside taper.Sem analysis determined damage over the majority of the surface with severe corrosion attack and abundant corrosion debris.The additional information does not change the outcome of the previous investigation.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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