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Model Number N/A |
Device Problem
Unstable (1667)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/04/2024 |
Event Type
malfunction
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).E1 telephone number: (b)(6).G2 foreign: lithuania.Evaluation and investigation are in process.Once the investigation is complete, a supplemental report will be filed.
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Event Description
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It was reported that outside of surgery on (b)(6) 2024, motor does not withstand nominal loading.There was no patient involvement, impact, or harm.Due diligence information complete.
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.The following sections were updated/corrected: h11 review of the most recent repair record determined the motor speeds were unstable and the motor was corroded.The motor was replaced and resolved the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.The event is confirmed.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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Event Description
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It was reported that outside of surgery on (b)(6) 2024, motor does not withstand nominal loading.There was no patient involvement, impact, or harm.Due diligence information complete.
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Search Alerts/Recalls
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