Internal reference number: case (b)(4).H3, h6: this complaint was opened by smith+nephew to document a patient complication identified through a review of clinical evidence from literature sources that includes reference to the use of a smith+nephew product.The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.Alexander w.Glover, alasdair j.A.Santini, john s.Davidson, jill a.Pope.Mid- to long-term survivorship of oxidised zirconium total knee replacements performed in patients under 50 years of age,the knee, volume 25, issue 4, 2018, pages 617-622, issn 0968-0160, https://doi.Org/10.1016/j.Knee.2018.03.014.
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It was reported that on literature review "mid- to long-term survivorship of oxidized zirconium total knee replacements performed in patients under 50 years of age", 1 patient following a fall required revision surgery due to aseptic loosening beneath the tibial component at one year post-operatively.During the revision surgery only the tibial component was explanted, the femoral component was found to be well fixed.Patient outcome is unknown.No further information is available.
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