SMITH & NEPHEW ORTHOPAEDICS LTD UNKNOWN BIRMINGHAM HIP MODULAR HEAD (BHMH); PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
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Catalog Number UNKN01102109 |
Device Problems
Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Metal Related Pathology (4530)
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Event Date 02/16/2022 |
Event Type
Injury
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Manufacturer Narrative
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Internal complaint reference: (b)(4).Pietiläinen, s., lindström, m., laaksonen, i., venäläinen, m.S., lankinen, p., & mäkelä, k.T.(2022).Long-term blood metal ion levels and clinical outcome after birmingham hip arthroplasty.Scandinavian journal of surgery,111(1),14574969211066197.Doi: doi.Org/10.1177/14574969211066197.
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Event Description
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It was reported that on literature review "long-term blood metal ion levels and clinical outcome after birmingham hip arthroplasty," 2 patients with unilateral bhr tha surgery and 1 patient with bilateral bhr tha had a revision surgery due to metallosis.Further information is unknown.
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Manufacturer Narrative
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H6: medical device problem code.
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Manufacturer Narrative
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Section h10: it was reported that on literature review "long-term blood metal ion levels and clinical outcome after birmingham hip arthroplasty ", 2 patients with unilateral bhr tha surgery and 1 patient with bilateral bhr tha had a revision surgery due to metallosis.Further information is unknown.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 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.Modular heads are no longer sold, therefore there is no live risk file to review.No further actions are required at this time.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.Internal complaint reference number: (b)(4).
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