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 Problem
Fracture (1260)
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Patient Problem
Failure of Implant (1924)
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Event Date 01/01/2016 |
Event Type
Injury
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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¿ 2.7 years after a bhr surgery, one (1) patient had an acetabular fracture after a fall.Revision surgery was performed to exchange the cup for an r3 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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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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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¿ 2.7 years after a bhr surgery, one (1) patient had an acetabular fracture after a fall.Revision surgery was performed to exchange the cup for an r3 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, a complaint history review, 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 fall, 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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Search Alerts/Recalls
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