Linkbio complaints was notified on (b)(6) 2022 by sales rep r.S.That a revision surgery was performed by dr.Db because a connection component had a screw that was starting to back out.A ronguer had to be used to back it out.The connection component and the femoral component were replaced, as the femoral component was loose.The revision was performed because the patient had metallosis.Rep stated that they have seen it before, that they can see poly wear from the screw, and wear to the screw head and some tissue wear.[customer].
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Linkbio complaints was notified on 2022-07-15 by r.S., that a revision surgery was performed by dr.(b)(6) because a connection component had a screw that was starting to back out.A ronguer had to be used to back it out.The connection component and the femoral component were replaced, as the femoral component was loose.The revision was performed because the patient had metallosis.R.Stated that they have seen it before, that they can see poly wear from the screw, and wear to the screw head and some tissue wear.Scans and/or images have been requested.Updated 2022-10-14, information in phone call with (b)(6), confirmed that the explanted parts were discarded on the day of the surgery (b)(6) 2022.[customer].
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