Model Number N/A |
Device Problems
Positioning Failure (1158); Difficult to Insert (1316)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/28/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Concomitant medical products: associated product tibia cemented 5 degree stemmed right size e item# 42532007102, lot# 64721507.Report source: (b)(6).Customer has indicated that the product will 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 that during a knee procedure, the surgeon failed to insert an articular surface to the tibial component.Several attempts were made and he confirmed that there was no cement or third particles between the articular surface and tibial component.Subsequently, a backup was used to complete the procedure.Attempts to obtain additional information have been made; however, no more information is available.
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Manufacturer Narrative
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This follow-up is being submitted to relay additional information.Visual inspection of the returned articular surface found that the dovetail feature was flared out.Medical records were not provided.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.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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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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