SMITH & NEPHEW ORTHOPAEDICS LTD UNKN R3 METAL LINER IMPL; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
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Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bacterial Infection (1735); Fluid Discharge (2686)
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Event Date 09/17/2019 |
Event Type
Injury
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Event Description
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It was reported that, on literature review "midterm outcomes of total hip arthroplasty with a modular birmingham head", one (1) patient who underwent primary surgery with a r3-tha construct required a revision surgery due to a postoperative chronic wound drainage which was treated with an irrigation and debridement and an r3 liner exchange at 2 months with the subsequent resolution of the symptoms.A culture was performed and was positive for staphylococcus aureus.No further information is available.
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Manufacturer Narrative
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Internal complaint reference: (b)(4).Cushnie, d.W., lanting, b.A., mccalden, r., naudie, d.D., & howard, j.L.(2021).Midterm outcomes of total hip arthroplasty with a modular birmingham head.Hip international, 31(1), 103-108.Doi: doi.Org/10.1177/1120700019877389.
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Manufacturer Narrative
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H10: additional information in h6 (health effect - clinical code and health effect - impact code).H3, h6.It was reported through a literature article that an irrigation, debridement and revision surgery was performed due to infection.The r3 liner was removed.As of today, the implanted devices, all of which were used in treatment, have not been returned for evaluation.As no device part or batch numbers were provided for investigation, a complaint history, manufacturing record and device labelling / ifu review could not be performed.If more information is received, this investigation will be reopened.R3 liners have been phased out from the market and as a result there is no live risk management file to review.Therefore, an evaluation of failure modes is not required.A review of historic escalation actions related to the products and similar complaint events was performed.Following the review, no prior applicable escalation actions were identified.The literature article was reviewed.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.Should additional medical information be provided this complaint will be re-assessed.Without additional information we cannot advance the investigation or confirm this complaint; our investigation remains inconclusive, and a definitive root cause cannot be determined.Based on the limited information provided we are unable to speculate on specific factors known to contribute to the alleged fault.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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