Bilateral patient.It was reported that, after an unspecified bhr prosthesis construct had been implanted on the patient¿s left hip in or around 2007, the patient has experienced ongoing pain and other unspecified symptoms consistent with metal-on-metal failure.The patient¿s cobalt levels were around the 50¿s (presumably ppb) when a revision surgery of the bhr right hip implants was performed on (b)(6) 2020.The contribution of this hip to the reported cobalt levels could not be discarded at this moment.It is unknown if a revision procedure has already been advised or performed by a health care professional.The patient¿s health status is not known.
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H3, h6: it was reported that, after an unspecified bhr prosthesis construct had been implanted on the patient¿s left hip in or around 2007, the patient has experienced ongoing pain and other unspecified symptoms consistent with metal-on-metal failure.It is unknown if a revision procedure has already been advised or performed by a health care professional, therefore the devices, used in treatment, were not available for analysis.As no device part and batch numbers were provided for investigation, a complaint history review, manufacturing record review, device labelling / ifu review could not be performed.If more information is received, this investigation will be reopened.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.A risk management review was performed for the acetabular cup and femoral head.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.Based on the reported symptoms it cannot be concluded that the events/clinical reactions (cobalt levels around the 50¿s) were associated with a mal-performance of the implant.The patient impact cannot be determined at this time.No further clinical assessment is warranted at this time.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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Bilateral patient.It was reported that, after an unspecified bhr prosthesis construct had been implanted on the patient¿s left hip in or around 2007, the patient has experienced ongoing pain and other unspecified symptoms consistent with metal-on-metal failure.The patient¿s cobalt levels were around the 50¿s (presumably ppb) when a revision surgery of the bhr right hip implants was performed on (b)(6) 2020 (covered in (b)(4)).The contribution of this hip to the reported cobalt levels could not be discarded at this moment.It is unknown if a revision procedure has already been advised or performed by a health care professional.The patient¿s health status is not known.((b)(4)).
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