Model Number N/A |
Device Problem
Difficult to Remove (1528)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/06/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Additional concomitant medical products: item# 00641802802 al fm hd 28 x 0mm (12/14) lot# 52887200; item# 00632005028 liner 20 degree elevated rim 28 mm i.D.For use with 50/52/54 mm o.D.Shells lot# 79803700; item# 65786200000 set, fm taper 19/20 hatcp lot# 63131000.(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.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 surgeon was unable to take liner out of the cup as locking ring was jammed.Liner was cut and locking ring removed from cup.Locking ring replaced.Attempts were made to obtain additional information; however, none is available.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Updated: reported event was confirmed by provided photographs.Visual inspection of photographs determined that the locking ring was bent.As reported, the liner was cut and broken.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event 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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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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