SMITH & NEPHEW ORTHOPAEDICS AG BICON-PLUS SHELL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
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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); Erosion (1750)
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Event Date 06/11/2002 |
Event Type
Injury
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Manufacturer Narrative
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Internal complaint reference: (b)(4).Korovessis, p., petsinis, g., repanti, m., papazisis, z., iliopoulos, p., & soucacos, p.N.(2002).Short-term results with the zweymueller-sl metal-on-metal total hip arthroplasty.European journal of orthopaedic surgery & traumatology, 12(2), 81-89.
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Event Description
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It was reported that, on the literature review "short-term results with the zweymueller-sl metal-on-metal total hip arthroplasty", a total of 266 patients underwent an index surgery where a bicon plus shell and a sl-plus stem were implanted as part of a total hip replacement procedure.One (1) patient showed asymptomatic radiolucent areas in zones 2 and 3 around the socket, with a chronic sinus-bacterium to the anterior-lateral upper third of the thigh 48 months postoperatively.This patient was unwilling to undergo revision at the time and was characterised as pending revision.Further information is unknown.
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Manufacturer Narrative
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Section h10: in the study of korovessis, p., et.Al.[1], a total of 266 patients underwent an index surgery where a bicon plus shell and a sl-plus stem were implanted as part of a total hip replacement procedure.One (1) patient showed asymptomatic radiolucent areas in zones 2 and 3 around the socket, with a chronic sinus-bacterium to the anterior-lateral upper third of the thigh 48 months postoperatively.This patient was unwilling to undergo revision at the time and was characterised as pending revision.The complaint device, used in treatment, was not received for investigation and a visual inspection could not be performed.The exact part and batch number of the device is not known.Therefore, the batch record review could not be performed and it is not possible to investigate whether the reported devices met manufacturing specifications upon release for distribution.A complaint history review was performed.The occurrence of the reported failure mode is within its expected risk level as per risk management.Furthermore, the instructions for use indicates several possible adverse effects resulting from a hip arthroplasty.A review of the risk management documentation verifies the failure mode and severity of the reported issue.Due to insufficient information it is not possible to perform a review of past corrective actions.For the medical investigation, no relevant supporting clinical information could be provided.Therefore, a thorough clinical assessment cannot be performed at this time.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined.Should any additional clinical information be provided, this complaint will be re-evaluated.Based on the performed investigations, a relationship between the reported devices and the reported incidents cannot be excluded, but the root cause of the problem stays undetermined due to insufficient information.A relationship between the reported event and the device cannot be confirmed.Due to insufficient information it is not possible to speculate about factors which could have contributed to the reported event.To date, no further actions will be taken.Smith and nephew will monitor the devices for further similar issues.[1]: korovessis, p., petsinis, g., repanti, m., papazisis, z., iliopoulos, p., & soucacos, p.N.(2002).Short-term results with the zweymueller-sl metal-on-metal total hip arthroplasty.Résultats précoces avec la prothèse de hanche métal-métal zweymueller-sl.European journal of orthopaedic surgery & traumatology : orthopedie traumatologie, 12(2), 81¿89.Https://doi.Org/10.1007/s00590-002-0025-6.Internal complaint reference number: (b)(4).
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