Model Number N/A |
Device Problem
Device Damaged Prior to Use (2284)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: provisional liner part #00500305028, lot# 60012989: 0001822565-2019-01411.
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Event Description
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It was reported that this instrument broke.No known patient involvement.Attempts have been 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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Complaint sample was evaluated and the reported event was confirmed.Lot 62350241 was returned with locking assembled with the product and identified nicks and damages on it.The devices returned had potential field service ages from 5 years to 20 years.It is unknown how many times the devices were used.Device history record (dhr) was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to wear and tear of the devices.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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