It was reported that the plaintiff underwent a left total hip arthroplasty metal-on-metal articulation approximately 10 years ago.The patient experienced symptomatic mechanical sounds, squeaking and elevated metal cobalt and chrome levels.The patient had a revision surgery on (b)(6) 2022 to treat these adverse events.During this procedure, the bhr modular head was explanted and replaced with an oxinium femoral head and a competitors liner.The current health status of the patient is unknown.
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H3, h6: it was reported that the patient was revised due to symptomatic mechanical sounds, squeaking and elevated metal cobalt and chromium levels.The devices, used in treatment, were not returned for analysis.As no device part and batch numbers were provided for investigation, a complaint history review, manufacturing record review, device labelling / ifu, or escalation actions review could not be performed.If more information is received, this investigation will be reopened.A risk management review was performed for the devices involved.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.The clinical information provided, of squeaking, elevated metal cobalt and chrome levels, and metallic staining may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.It cannot be concluded that the reported clinical findings are associated with the implant failure.Without additional information we cannot further investigate or confirm the reported complaint.The 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 and trauma to the joint replacement.If the products or additional information become available in the future, this case will be reopened.Based on this investigation, the need for corrective or preventative action is not indicated.
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