Model Number N/A |
Device Problem
Device Contamination With Biological Material (2908)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Information (3190)
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Event Date 10/20/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show the lot released with no recorded anomaly or deviation.The following sections could not be completed with the limited information provided.(b)(4).
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Event Description
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During a shoulder arthroplasty, contaminate was found under the metal plate on the back of the humeral trial heads.All the trials were then taken apart, decontaminated again, reassembled and used to complete the procedure with a two hour delay.
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Manufacturer Narrative
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This follow-up report is being filed to relay additional and corrected information, which was unknown at the time of the initial medwatch.This report is number 1 of 23 mdrs filed for the same patient (reference 1825034-2017-00668 - 00689 and 1825034-2016-04742).
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Event Description
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During a shoulder arthroplasty, contaminate was found under the metal plate on the back of the humeral trial heads.After the procedure, all the trials were then taken apart, decontaminated again, reassembled to be used for the next case that was postponed by two hours for this second decontamination of the trials.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Device history records were reviewed with no discrepancies found.Product was visually examined.Externally, the products do not appear to have any bioburden on the head or plate.To further investigate, several provisionals (both versadial and comprehensive) were disassembled.Upon disassembly, there was notable staining indicative of bioburden under the plate; therefore, the complaint is confirmed.Investigation results concluded that the root cause of the complaint is a design related issue.A design change has been initiated to address the reported event.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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Search Alerts/Recalls
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