Model Number N/A |
Device Problem
Difficult to Remove (1528)
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Patient Problem
No Code Available (3191)
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Event Date 02/28/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: item# 110030158 dm univ prov brg 28 x 44mm lot# zb170502.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr's submitted for this complaint: 0001825034 - 2018 - 02225.
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Event Description
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It was reported that during a hip arthroplasty, the surgeon was unable to dislocate the hip after completing trialing.After multiple attempts, the surgeon decided to cut the trials out with a saw.There was a 45 minute delay in procedure as a result.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(4).Product was not returned to zimmer biomet for evaluation.This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of associated device (associated mdr) which indicated through visual inspection wear marks, cutting marks and few pieces were missing from the returned instrument.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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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Search Alerts/Recalls
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