SMITH & NEPHEW, INC. TITANIUM MODULAR HEAD SLEEVE +0MM SHORT; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
|
Back to Search Results |
|
Catalog Number 71344247 |
Device Problem
Insufficient Information (3190)
|
Patient Problem
Injury (2348)
|
Event Date 06/26/2018 |
Event Type
Injury
|
Event Description
|
It was reported that patient had increased nickel, titanium and vanadium levels.No treatment has been given to patient.
|
|
Manufacturer Narrative
|
The associated synergy porous plus standard offset stem, modular head sleeve and r3 0 hole acetabular shell were not returned for evaluation.The devices were manufactured in 2010 and 2011.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.Without the return of the actual product involved, our investigation of this report is inconclusive.A clinical evaluation noted that no clinical relevant documents were provided to conduct a thorough medical assessment.No medical assessment is warranted at this time.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.
|
|
Search Alerts/Recalls
|
|
|