SMITH & NEPHEW ORTHOPAEDICS LTD UNKN BIRMINGHAM HIP RESURFACING (BHR) CUP (UNKN TYPE); PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
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Catalog Number UNKNOWN |
Device Problems
Malposition of Device (2616); Biocompatibility (2886); Migration (4003)
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Patient Problems
Infiltration into Tissue (1931); Pain (1994); Deformity/ Disfigurement (2360); Metal Related Pathology (4530)
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Event Date 01/01/2016 |
Event Type
Injury
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Manufacturer Narrative
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Internal complaint reference: (b)(4).Samuel, l.T., zuke, w.A., mahmood, s., munim, m.A., alamir, p., & brooks, p.J.(2022).Hip resurfacing: a single surgeon us series with minimum ten-year follow-up.The journal of arthroplasty.Doi: https://doi.Org/10.1016/j.Arth.2022.04.008.
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Event Description
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It was reported that on literature review "hip resurfacing: a single surgeon u.S.Series with minimum ten-year follow-up¿ 9.3 years after a bhr surgery, one (1) patient had pain, high levels of metal ions (57 ppb of co and 18 ppb of cr), and cup malposition with excessive anteversion.Revision surgery was performed to explant the cup.The patient outcome and current health status is unknown.No further information is available.
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Manufacturer Narrative
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H3, h6.It was reported on literature review that one patient had a revision surgery due to pain, high levels of metal ions, and cup malposition.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.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 acetabular cup.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.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be rendered nor can the root cause of the reported failure be determined.However, we cannot rule out the reported cup malposition with excessive anteversion as a likely contributory factor.Should any additional relevant clinical information be provided, this complaint would be re-assessed.Based on the information provided, including the elevated ion levels, we can confirm the reported complaint; however 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 device or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.H11: corrected information in h6 (health effect - clinical code and health effect - impact code).
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