ZIMMER BIOMET, INC. ARTICULAR SURFACE PROVISIONAL SIZE GH 10 MM HEIGHT USE WITH PLATE 7,8,9,10; INSTRUMENT, KNEE
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Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/06/2020 |
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.
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Event Description
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It was reported that during an initial total knee arthroplasty, the provisional fractured after being struck with a mallet.No adverse events have been reported as a result of the malfunction.
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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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This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.Investigation results concluded that the reported event is attributed to the user hitting the instrument with a mallet.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.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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