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It was reported that, after an r3-tha construct had been implanted on the patient¿s left hip on (b)(6) 2009, the patient experienced metal reaction, pseudotumor formation and loosening of the femoral stem prosthesis.A revision surgery was conducted on (b)(6) 2020 to treat this adverse event.Intraoperatively, metal debris was found between the modular trunnion and the actual stem, along with a large hematoma that was evacuated.All the components except the acetabular shell were revised and exchanged with a new thr system.The procedure was completed without any complications.The patient¿s outcome is not known.
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It was reported that a left hip revision surgery was performed due to metal reaction, pseudotumor formation and loosening of the femoral stem prosthesis.Metal debris and hematoma were found intraoperatively.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.A review of the historical complaints data for the devices concerned was performed using batch numbers, part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.Similar complaints have been identified for the modular sleeve.No other similar complaints have been identified for the modular head, r3 liner, r3 shell and femoral component.This will continue to be monitored for the r3 shell and femoral component.However, as the modular head, modular sleeve and r3 metal liner are no longer sold, no action is to be taken.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All released devices involved met manufacturing specifications upon release for distribution.Review of the product 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, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible.No further escalation actions are required.The available medical documents were reviewed.The intraoperative findings of a grossly loose stem, large hematoma, and dark metal debris between the modular trunnion and the actual stem may be consistent with the reported pseudotumor and metal reaction.However, the clinical root cause of the reported clinical reaction/event cannot be confirmed.The patient impact beyond the reported events cannot be determined with the limited information provided.Based on the available information we can confirm the reported complaint, however without further information our investigation remains inconclusive, and 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.
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