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Section h3, h6: it was reported that, after undergoing right hip resurfacing (bhr) due to osteoarthritis, the patient experienced pain, elevated metal ion levels and localized metallosis.This adverse event was addressed by conducting a revision surgery, during which both resurfacing components were explanted.The patient was taken to recovery room in stable condition.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 alleged devices 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 cup and head.This will continue to be monitored via routine trending, however it should be noted that these devices are no longer sold.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.The 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.A clinical root cause could not be determined.The reported pain, elevated metal ions, and intraoperative findings of grayish appearing tissue are consistent with the reported metallosis.However, the clinical root cause of the metallosis cannot be 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.
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It was reported that, after undergoing right hip resurfacing (bhr) on (b)(6) 2009 due to osteoarthritis, the patient experienced pain, elevated metal ion levels and localized metallosis.This adverse event was addressed by conducting a revision surgery on (b)(6) 2015, during which both resurfacing components were explanted.During this procedure, some focal grayish-appearing tissue was observed anteromedially within the capsule, which was though to represent melanosis.Conversion to a competitor¿s tha system (stryker) was successfully performed.A sterile dressing was applied, and the patient was taken to recovery room in stable condition.
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