Model Number N/A |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
Insufficient Information (4580)
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Event Date 10/05/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.The 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.
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Event Description
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During a right knee arthroplasty a left knee femoral implant was implanted.It was further reported that the device was incorrectly labeled as a right femoral implant.At this time no additional patient consequences have been reported.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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This follow-up is being submitted to relay additional information.The results of the investigation are as follows: no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.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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