SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
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Model Number 74121150 |
Device Problem
Biocompatibility (2886)
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Patient Problems
Infiltration into Tissue (1931); Inflammation (1932); Pain (1994); Discomfort (2330); 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¿ 4.9 years after a bhr surgery, one patient had pain, high levels of metal ions (47.6 ppb of co and 25.2 ppb of cr), cup malposition with an inclination of 56° and effusion.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 that on literature review "hip resurfacing: a single surgeon u.S.Series with minimum ten-year follow-up¿ 4.9 years after a bhr surgery, one (1) patient had pain, high levels of metal ions (47.6 ppb of co and 25.2 ppb of cr), cup malposition with an inclination of 56° and effusion.Revision surgery was performed to explant the cup.The patient outcome and current health status is unknown.No further information is available.As no device part and batch numbers were provided for investigation for the acetabular cup, a complaint history review, manufacturing record review, device labelling / ifu, historic escalation actions review could not be performed.Without a definitive batch number, a complete review of the historical complaints data cannot be performed for the femoral head.A review of historical complaints data was performed using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe prior 12 months as of the complaint aware date.Other similar complaints have been identified for the part number and the reported failure mode, and this failure will continue to be monitored.As no device batch numbers were provided for investigation for the femoral head, manufacturing record review, device labelling / ifu, historic escalation actions review could not be performed.If more information is received, this investigation will be reopened.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.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 an inclination of 56°, as a likely contributory factor.The impact to the patient beyond that which has already been reported cannot be confirmed nor concluded.Should any additional relevant clinical information be provided, this complaint would be re-assessed.Based on the information provided we cannot confirm or further investigate the reported complaint, our investigation remains inconclusive, and a definitive root cause cannot be determined.Additionally, specific factors known to contribute to the alleged fault cannot be provided due to the insufficient information.If additional information becomes available in the future, this case will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.
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