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Model Number N/A |
Device Problems
Power Problem (3010); Noise, Audible (3273)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/03/2023 |
Event Type
malfunction
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Manufacturer Narrative
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This complaint is recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined the motor speed was unstable and the unit was out of calibration at 20 reading.The motor, shaft bearings and sleeve bearings were replaced and resolved the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing.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.E1 telephone number: (b)(6).G2 country: spain.
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Event Description
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It was reported that during testing the device makes a noise and it does not have power.There was no patient involvement.During product evaluation, the motor speed was unstable.Due diligence is complete and there is no additional information available.There were no adverse events associated with this malfunction.
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Search Alerts/Recalls
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