It was reported that there was an issue with knee components.As a result of having the product implanted the patient has experienced knee pain, loosening and instability of the implant.The primary surgery occurred on (b)(6) 2014 and there was no reported revision surgery.All available information has been provided at this time, if additional information becomes available the complaint will be updated accordingly.The adverse event / malfunction is filed under reference (b)(4).Involved components: no182z(femur cemented f3 rm).No157z(tibial cemented t2 rm).Nl471(pe insert t2 rm/lm 7 mm).Associated medwatches: 2916714-2020-00450.2916714-2020-00451.
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