|
It was reported that, a bilateral plaintiff underwent a left bhr surgery on (b)(6) 2012 and was later diagnosed with high chromium cobalt levels on (b)(6) 2022.Therefore, a revision surgery was performed on (b)(6) 2023, during which a large area of frank metal-stained tissue that herniated through the fascia was found.The acetabular cup was noticed to be in good position and well fixed, therefore it was kept in place and the hip was converted into a dual mobility birmingham with a djo empowr total hip system.The patient was transferred to the recovery room in stable condition.
|
|
It was reported that, a bilateral patient underwent a left bhr surgery, and was later diagnosed with high chromium cobalt levels.Therefore a revision surgery was performed, during which a large area of frank metal stained tissue that herniated through the fascia was found.The acetabular cup was noticed to be in good position and well fixed, therefore it was kept in place and the hip was converted into a total hip arthroplasty.The patient was transferred to the recovery room in stable condition.As of today, the implanted femoral head used in treatment has not been returned for evaluation and the cup remains implanted, therefore cannot be tested.Without a definitive batch number, a complete review of the historical complaints data cannot be performed for the alleged devices.A review of historical complaints data was performed using the part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.Similar complaints have been identified for the head and none for the cup, and this failure will continue to be monitored.As no device batch numbers were provided for investigation, manufacturing record review could not be performed.If more information is received, this investigation will be reopened.The review of the most recent ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.No further actions are required at this time.A review of historic escalation actions related to the products and similar complaint events was performed.Following the review, no prior applicable escalation actions were identified.No further escalation actions are required.The available medical documents were reviewed.A clinical root cause could not be determined.The elevated metal ions, and large area of frank metal-stained tissue may be consistent with metal debris: however, a clinical root cause cannot be definitively confirmed.The patient impact beyond the reported revision could not be determined.Based on the information provided, further investigation of the reported complaint cannot be carried out and remains inconclusive.A definitive root cause cannot be determined.Specific factors known to contribute to the alleged fault are excessive physical activity levels, unreasonable stress on replacement system, excessive patient weight, trauma to the joint replacement, loosening of components may increase production of wear particles and accelerate damage to the bone.Should the devices or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.
|
