SMITH & NEPHEW, INC. UNKNOWN SPECTRON EF STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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Catalog Number UNKNOWN |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Osteolysis (2377); Inadequate Osseointegration (2646)
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Event Date 01/31/2022 |
Event Type
Injury
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Manufacturer Narrative
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H10: internal complaint reference: case (b)(4).H3, h6: this complaint was opened by smith+nephew to document a patient complication identified through a review of clinical evidence from literature sources that includes reference to the use of a smith+nephew product.The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.Doi: https://doi.Org/10.1002/jbm.B.35023.Wolf, s., johannessen, a.C., ellison, p., furnes, o., hallan, g., rogg, k.,.& høl, p.J.(2022).Inflammatory tissue reactions around aseptically loose cemented hip prostheses: a retrieval study of the spectron ef stem with reflection all-poly acetabular cup.Journal of biomedical materials research part b: applied biomaterials, 110(7), 1624-1636.
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Event Description
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It was reported that on literature review "inflammatory tissue reactions around aseptically loose cemented hip prostheses: a retrieval study of the spectron ef stem with reflection all-poly acetabular cup" 108 months after a tha surgery, where an spectron ef stem and a reflection non-crosslinked all-polly cup were implanted, the patient underwent a revision surgery due to loosening of the cup and the stem, and osteolysis.The study determined that both the stem and the cup were worn, additionally pe, cr, co and zr particles were present in the periprosthetic tissue.Current health status of the patient is unknown.No further information is available.
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Manufacturer Narrative
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H10: additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.A response was received from the publication author, indicating that the polyethylene (pe) particles liberated by the cup's wear may have been the primary cause of the osteolysis in the femur, as well as the loosening of the stem.Therefore, the stem will be handled as a concomitant device under report number 1020279-2024-00230.
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Search Alerts/Recalls
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