SMITH & NEPHEW, INC. R3 3 HOLE HA CTD ACET SHELL 60MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
|
Back to Search Results |
|
Catalog Number 71331960 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Foreign Body Reaction (1868); Arthralgia (2355)
|
Event Date 08/22/2013 |
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 the national joint registry from united kingdom 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, after undergoing a right thr revision surgery on (b)(6) 2011 due to adverse soft tissue reaction to particulate debris, the patient experienced unexplained pain and adverse soft tissue reaction to particulate debris.This adverse event was treated by performing a second revision surgery on (b)(6) 2013.During this procedure, all the prosthesis components were explanted and replaced with a competitors hip system.This information was provided by the national joint registry of the united kingdom, as part of a retrospective data collection of patients who underwent a first thr revision surgery with a hip prosthesis construct that included a polarstem femoral prosthesis and that required a second revision surgery due to specific reasons.As such, no further information will be available.
|
|
Search Alerts/Recalls
|
|
|