SMITH & NEPHEW ORTHOPAEDICS LTD UNKN BIRMINGHAM HIP RESURFACING (BHR) CUP (UNKN TYPE); PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
|
Back to Search Results |
|
Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Pain (1994); Balance Problems (4401); Metal Related Pathology (4530)
|
Event Date 07/01/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
It was reported that a revision surgery was performed on the patients left hip implant on (b)(6) 2018.The revision surgery was performed due to burning sensations, pain, discomfort, deteriorating health, mental fuzziness, significant malaise, instability, lack of balance, metallosis, cobalt, and chromium poisoning and other serious neurologic deficits.The patient outcome is unknown.
|
|
Manufacturer Narrative
|
It was reported that left hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.As no device part and batch numbers were provided for investigation, a complaint history review, manufacturing record review and device labelling/ifu review could not be performed.If more information is received, this investigation will be reopened.A risk management review was performed.No additional risks were identified as result of the reported event and no further actions are required at this time.Smith and nephew has not received adequate materials to fully evaluate the complaint.It is noted, the product will be returned.If additional clinically relevant materials are later received and/or the product evaluation offers information that is clinically relevant to the medical investigation, then the case may be re-opened for further evaluation.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.
|
|
Search Alerts/Recalls
|
|
|