Model Number N/A |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/16/2016 |
Event Type
No Answer Provided
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Manufacturer Narrative
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(b)(4).Corrective action has been initiated to address the reported issue.This report is number 2 of 2 mdrs filed for the same event (reference 1825034-2016-04293 / 04294).
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Event Description
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During an open reduction internal fixation procedure for a fractured acetabulum it was noticed that a hi-wall liner was packaged as a dual mobility bearing.Another bearing was available and used to complete the procedure without delay.
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Manufacturer Narrative
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(b)(6).This follow up report is being filed to relay corrected and additional information.Review of device history records found these units were released to distributor with no deviations or anomalies.Visual examination of the returned product confirmed the complaint as the box and product did not match.Complaint history review identified an issue which was addressed.The root cause is likely that the lots were mixed when they were prepped for the sterilization operation.Corrective action has been initiated to address reported issue.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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Search Alerts/Recalls
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