STANMORE IMPLANTS WORLDWIDE FEM KNEE W/EPI R STD; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number MKFE-RSTD |
Device Problem
Naturally Worn (2988)
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Patient Problem
Pain (1994)
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Event Date 01/11/2023 |
Event Type
Injury
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Manufacturer Narrative
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Reported event: an event regarding wear involving a mets, distal femoral replacement, femoral component was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: the implant for review is for distal femoral/proximal tibial replacement which was inserted on (b)(6) 2012.The surgeon reported major wear of the prosthesis and metallosis which were observed during debridement and synovectomy surgery.The clinical images were not provided for review.Considering that the femoral and tibial components were in situ was over 10 years, normal wear and tear including metallosis are expected.Therefore, this review can support the clinical report and surgical observation.Device history review: review of the product history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the lot referenced.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including pathology reports, additional pre and post-surgery x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.Device not returned.
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Event Description
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Customer reported that: "35-year-old patient hospitalized for the replacement of a right knee prosthesis initially inserted on (b)(6) 2012 in the context of a carcinological resection of the lower extremity of the left femur for osteosarcoma.Since (b)(6) 2022 the patient has been complaining of frequent mechanical pain phenomena.The follow-up radiograph did not show any signs of loosening, but was consistent with prosthetic wear.Surgical decision of prosthetic revision.During the revision surgery on (b)(6) 2023, after arthrotomy, the surgeon noted major wear of the prosthetic wear of the prosthetic components and metallosis.Metallosis.A massive debridement of the of the entire joint and a synovectomy.The prosthesis could not be due to an error in the control of the devices.A new operation with implantation of a new prosthesis with an adapted size was performed on (b)(6) 2023.Anatomical and pathological samples were taken intraoperatively were taken intraoperatively on (b)(6) 2023, showing macrophages including metallic metal deposits.".
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