|
It was reported that left hip revision surgery was performed.During the revision, the hemi head, modular sleeve and r3 liner were removed.The r3 shell and anthology stem remained implanted.As of today, device return and additional information has been requested for this complaint but has not become available.In the absence of the actual devices, the production records were reviewed for the known devices reportedly involved in this incident.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.The available medical documents were reviewed.The intraoperative findings of debris on the trunnion of the sleeve and the stem of the acetabulum and loss of cartilage.The x-rays revealed the trochanteric osteotomy is in position.However, the screws are broken, but it has not migrated superiorly.Metallic ions were found to be chromium 3.8 mcg/l & cobalt 9.0mcg/l.The gluteus median tendon was torn and detached.: the specimen is received without fixative labeled ¿left hip hardware¿ is of a purple and silver metallic femoral head.These findings are all consistent with trunnionosis and adverse tissue reaction.Without the support of imaging and the analysis of the explanted components the root cause of the clinical findings cannot be confirmed, and it cannot be concluded that the reported clinical findings were associated with mal-performance of the implant.The patient impact beyond the pain, revision and expected transient post op convalescence period cannot be determined.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.Correction concomitant medical products.
|
