BIOMET UK LTD. OXFORD UNI TIB TRAY SZ E LM PMA; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL
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Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Joint Laxity (4526)
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Event Date 03/12/2024 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).D-10: oxf twin-peg cmntd fem lg pma, item# 161470, lot# 65766772.Oxf anat brg lt lg size 3 pma, item# 159554, lot# 164780.Refobacin bc r 1x40 us, item# 110034355, lot# ax18ad0402.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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It was reported that the patient underwent an initial partial left knee replacement.Subsequently, the patient has moderate pain and medial collateral ligament instability.The patient sustained two falls, both falls the patient reported tripping.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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This follow-up report is being submitted to relay additional corrected information.The products remain implanted; therefore, visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Reported event was confirmed by review of medical records.X-ray findings confirmed components in good position without evidence of loosening, neutral tracking patella.With the available information, a definitive root cause could not be determined.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.
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