Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Muscular Rigidity (1968); Pain (1994)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Date of birth: (b)(6).Implant date - unknown month and day in 2014.Event date and explant date - unknown month and day in 2017.Medical products: series a pat thn 34 3 peg, catalog # 184786, lot # unknown; tinbn vg int ps anat fm l 65mm ,catalog # 183128tnbn, lot # unknown; tnbn pol cocr fin tib tray 71, catalog # 141253tnbn, lot # unknown.Customer has indicated that the product will not be returned because product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001825034-2021-02130.Product location is unknown.
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Event Description
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It was reported that the patient underwent a knee arthroplasty.Subsequently, the patient was revised due to pain.It is unknown what products were revised.Attempt for further information has been made, but no further information has been provided.
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Event Description
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From additional information, it was reported that the patient presented with joint stiffness and a low range of motion, which is why arthrolysis, a maquet osteotomy and a patella baja were all performed.It was confirmed that the patient did not have a revision of zimmer biomet product.
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Manufacturer Narrative
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This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.
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Event Description
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It was reported patient underwent a revision procedure post implantation due to pain.The patient had joint stiffness and a low range of motion, which is why arthrolysis, a maquet osteotomy and a patella baja were all performed.Attempts to obtain additional information have been made; however, no more is available.
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Manufacturer Narrative
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Reported event was confirmed by review of medical records provided.Device was not returned.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause cannot be determined.Medical records review indicates there is chronic pain due to complication with patella resurfacing caused by avascular necrosis.Patient was revised in 2017 in a different hospital than the study center and reported chronic pain after revision.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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