Model Number N/A |
Device Problem
Off-Label Use (1494)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/13/2023 |
Event Type
Injury
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Event Description
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It was reported that an implant for the right side was implanted during left knee implantation.As the surgeon approved the range of motion, he decided to keep it.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(4).D10 ¿ associated products; oxf twin-peg cmntd fem md pma , item# 161469, lot# 085950.Oxf anat brg lt md size 3 pma, item# 159547, lot# 887160.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.
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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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(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h10.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Device is used for treatment.Medical records were not provided.A right oxford tibial component was implanted in the left knee.The root cause of the reported issue is attributed to user error.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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