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); 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¿ 8.3 years after a bhr surgery, one (1) patient had pain, high levels of metal ions (56.7 ppb of co and 29.8 ppb of cr), cup malposition with excessive anteversion and effusion.Revision surgery was performed to explant both implants.Competitor devices were implanted.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 the patient was revised due to pain, high levels of metal ions, cup malposition with excessive anteversion and effusion.The devices, used in treatment, were not returned for analysis.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 were identified for the part number and the reported failure mode.This will continue to be monitored.As no device batch numbers were provided for investigation, manufacturing record review, device labelling / ifu 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.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 required.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.The impact to the patient beyond that which has already been reported cannot be confirmed nor concluded.Therefore, no further medical assessment is warranted at this time.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.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.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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Manufacturer Narrative
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Results of investigation: it was reported that the patient was revised due to pain, high levels of metal ions, cup malposition with excessive anteversion and effusion.The devices, used in treatment, were not returned for analysis.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 were identified for the part number and the reported failure mode.This will continue to be monitored.As no device batch numbers were provided for investigation, manufacturing record review, device labelling / ifu 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.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 required.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.The impact to the patient beyond that which has already been reported cannot be confirmed nor concluded.Therefore, no further medical assessment is warranted at this time.Should any additional relevant clinical information be provided, this complaint would be re-assessed.Based on the information provided 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.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.Corrected data: h3, h6(health effect - clinical code, investigation findings).
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