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Model Number 5842-24-08 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Synovitis (2094); Swelling/ Edema (4577)
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Event Date 10/16/2020 |
Event Type
Injury
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Event Description
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It was reported that a patient underwent a left knee procedure.Subsequently, for two years post implantation, the patient has had persistent and ongoing pain, swelling, and difficulty with daily activities.The patient experiences a scraping sensation and sharp focal pain when the knee is bent past 90 degrees.At one year post implantation, two ultrasounds were completed which suggested synovitis and degenerative changes affecting the iliotibial band and the lateral collateral ligament.Medical evaluations and extensive rehabilitation have not improved symptoms and imaging studies reportedly show severe irritation to the lateral collateral ligament at the location of the implanted components.At this time, no further medical intervention has been reported and the products remain implanted.
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Manufacturer Narrative
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(b)(4).Concomitant medical products: tibial component precoat right medial/left lateral size 4, catalog#: 00584200402, lot#: 63838877.Femoral component high flex precoat for cemented use only right medial/left lateral, catalog#: 00584201502, lot#: 64654549.Palacos fast r+g 1x40, catalog#: 66056768, lot#: 95434925.Report source: foreign: australia.Multiple mdr reports have been filed for this event.Please see associated reports: 0001822565-2022-02494; 0001822565-2022-02496.Visual and dimensional evaluations could not be performed as no product was returned.Photograph provided shows that the left knee is swollen.Device history record was reviewed and no discrepancies related to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: patient xray and ultrasound show severe irritation to lcl, multiple orthopedic evaluations, patient is lean and fit at baseline.Root cause was unable to 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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Search Alerts/Recalls
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