Model Number N/A |
Device Problems
Positioning Failure (1158); Difficult to Insert (1316)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/03/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.(b)(4).Concomitant medical product(s): item # 42522100710 lot # 64417075 unknown tibial tray.Report source: foreign: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2019-00354.
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Event Description
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It was reported that during a total knee arthroplasty the surgeon was unable to lock persona mc 10mm surface to tibial tray.So the surgeon attempted to use a 11mm of persona mc surface but the same issue occurred again.Subsequently, the surgeon was able to complete the procedure with a cr 10mm surface.Attempts have made and no further information has been provided.
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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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Manufacturer Narrative
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(b)(4).This complaint was not confirmed.Visual examination of returned products found that both articular surfaces show signs of use (nicks or gouges) and the dovetail feature is flared.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.A definitive root cause cannot 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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