Mom medical records received.After review of the medical records, the patient was revised to address pseudotumor, elevated metal ions, neurolysis of sciatic nerve, complex wound of hip, heterotopic ossification and capsular redundancy.Operative note reported scars, metallosis, pseudotumor and metallic debris.There was a large amount of fluid present in the hip joint, sciatic nerve was compressed by the pseudotumor.There was also a large amount of capsular debris, pseudotumor and some heterotopic bone.Medical records indicate the cup was loosened and cystic changes were curetted from behind the cup.Doi: (b)(6) 2009; dor: (b)(6) 2012 ; right hip.
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Product complaint (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot :the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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