It was reported that, after a left bhr-tha on (b)(6) 2007 due to severe degenerative osteoarthritis, left hip coxa vara, chronic femoral impingement, and post scfe deformity.Plaintiff experiences swelling and high cobalt levels.Plaintiff underwent a revision surgery on (b)(6) 2021 where the modular head and stem was removed, and debridement of all fibrinous and infected tissue was performed but due to patient¿s cardiopulmonary status it was required to closed and wait for patient stabilization.Revision surgery was resume on (b)(6) 2021 where an acetabular component was removed, and it was found a large superior cyst inside the ilium.Patient status is unknown.
|
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, elevated cobalt was reported; however, no lab values or lab reports were provided.Although the reported swelling in the left hip, and intraoperative findings of gross purulence and infected tissue are consistent with the reported infection.The infection is highly likely of an exogenous nature, there is no evidence that our product contributed to the infection or the patient's declining cardiopulmonary status during the revision.The patient impact beyond the infection, revision and expected transient post-op convalescence period cannot be determined.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to traumatic injury, joint tightness, material in use, patient reaction, loss of sterility, damaged product, implant corrosion or wear, contamination, and post-operative healing issue.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
|