The alleged complaint is not confirmed.Microport was made aware of this event through uk njr registry data.It was indicated that this patient's femoral implants were revised due to an alleged tissue reaction.The revised products were not returned for investigation.No operative notes or other clinically relevant documentation is available to confirm this complaint.Review of the device history record (dhr) for these lots indicates that these products met all established acceptance criteria throughout the manufacturing process.Review of historical complaint data reveals no lot trends for the alleged complication.These products had been implanted for approximately 71 months at the time of revision.The alleged patient reaction is consistent with complications addressed by corrective and preventive action (capa)(b)(4).This capa found that, "the potential for a patient reaction when implanted with a profemur¿ cocr modular neck is a known risk for this product technology.A combination of patient and surgical factors can contribute to an elevated risk of an adverse patient reaction.These factors include, but are not limited to, patient sensitivity, surgical technique, patient weight and activity level." furthermore, the microport hip systems package insert ((b)(4)) lists "allergic reactions to materials; metal sensitivity; or reactions to wear debris that may lead to histological reactions, pseudotumor and aseptic lymphocytic vasculitis-associated lesions (alval)" as possible adverse effects of total hip arthroplasty.No further evaluations from the available information.
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