Allegedly, patient underwent in (b)(6) 2010 replacement of the right hip by means of a metal-metal prosthesis implantation, has developed pseudo-tumor from metal-metal coupling, with evidence of a cobalt dosage of 7.7 mg / l (compared to reference <1.0mg / l), causing aseptic loosening of the prosthesis and forcing it to undergo a prosthetic revision in 2014, of increased complexity due to the presence of the tumor mass.More tools since the onset of metallosis and, even more so, the development of pseudo-tumor represent clear typical consequences of metal / metal combinations.Only part numbers and lot numbers for the cup and stem were provided.
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Due to additional information received for this event and after further analysis from reliability engineering, it has been determined that there is no an alleged deficiency against this device.Therefore, this device has been considering as no complaint stated? and no longer reportable.Please void this report.
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