The product was not returned for evaluation due to unknown location.Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Current information is insufficient to permit conclusions as to the cause of the events.Event details and product identification was not provided for the patients mentioned in the journal article.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation: under possible adverse effects number 4: "loosening, migration, or fracture of the implants can occur due to loss of fixation, trauma, malalignment, malposition, non-union, bone resorption and/or excessive unusual and/or awkward movement and/or activity." 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.Emerson jr, r.H., & higgins, l.L.(2008).Unicompartmental knee arthroplasty with the oxford prosthesis in patients with medial compartment arthritis.The journal of bone and joint surgery, incorporated, 90-a, 118-122.(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 1825034 ¿ 2017 ¿ 08125 / 08141 / 08144 / 08145.(b)(4).Product location unknown.
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Information was received based on review of a journal article titled, "unicompartmental knee arthroplasty with the oxford prosthesis in patients with medial compartment arthritis." the article identified one (1) patient who developed femoral component loosening 3.7 years post unicompartmental knee arthroplasty, and underwent revision surgery.There has been no further information provided and the patient's outcome is unknown.
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