SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
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Catalog Number 74121146 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
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Patient Problems
Bone Fracture(s) (1870); Failure of Implant (1924); Inadequate Osseointegration (2646)
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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¿ 8.6 years after a bhr surgery, one patient developed subsidence and subacute fracture of the femoral component due to femoral head collapse.Revision surgery was performed to exchange the head for a dual mobility system from s+n.The patient outcome and current health status is unknown.No further information is available.
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Manufacturer Narrative
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Additional information added: a2, a3, h6 (component code, type of investigation, investigation findings, investigation conclusions), h7, h9.H9: z-2745-2015 through z-2747-2015.Results of investigation: it was reported from literature review that a patient underwent a bhr revision surgery due to femoral head collapse.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.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.Similar complaints have been identified for the femoral head.However, as the device is no longer sold, no action is to be taken.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 could not be performed.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.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.Corrected data: h3, h6 (health effect - clinical code).
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