SMITH & NEPHEW, INC. UNKN REFLECTION ALL-POLY CUP; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
|
Back to Search Results |
|
Catalog Number UNKNOWN |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
|
Patient Problem
Inadequate Osseointegration (2646)
|
Event Date 04/12/2016 |
Event Type
Injury
|
Manufacturer Narrative
|
Internal complaint reference: (b)(4).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.
|
|
Event Description
|
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" 158 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 loosinng of the cup and the stem.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.
|
|
Manufacturer Narrative
|
H10.Additional information added in a4, b5, b7, d6a, d6b, d10.H11.Corrected information in b3.
|
|
Event Description
|
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" 158 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 loosing of the cup and the stem.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.Also, it wa stated 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.Current health status of the patient is unknown.No further information is available.The primary tha was performed on (b)(6) 2003 and the revision surgery (b)(6) 2016.
|
|
Search Alerts/Recalls
|
|
|