Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Impaired Healing (2378); Fluid Discharge (2686)
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Event Date 08/23/2023 |
Event Type
Injury
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Event Description
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It was reported a patient underwent a left total knee.Subsequently, 1 day post-op the patient began to have wound drainage and was treated with dressing changes, a knee immobilizer, an ace wrap for compression, and prescribed oral keflex.Xarelto and physical therapy were also held during this time.Approximately 11 days post-op, the drainage was reported as resolved and further radiographic imaging identified no abnormalities.Attempts have been made and all available information has been provided.
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Manufacturer Narrative
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(b)(4).D10: 42572606201 - femur cemented cruciate retaining (cr) standard nitrided left size 7 - 66087300.42532007101 - tibia cemented 5 degree stemmed left size e - 65889766.42512200512 - articular surface fixed bearing ultracongruent (uc) left 12 mm height - 65279333.42540000032 - all poly patella cemented 32 mm diameter - 65990506.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.Once the investigation has been completed, a follow-up mdr will be submitted.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.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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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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