InjuryHSH
UNKNOWN STRYKER TIBIAL COMPONENT
Received Jan 4, 2013 · Event occurred Nov 15, 2012
Report 2249697-2013-90018 · MDR key 2911077
Device
Generic name
Implant
Manufacturer
Stryker Orthopaedics MahwahModel number
NACatalog number
UNK
Lot number
UNK
Product problems
- Insufficient Device Problem Information
Patient
65 YR
- No Code Available
Narrative
Additional Manufacturer Narrative
THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AS THEY REMAIN IMPLANTED. DEVICE HISTORY REVIEW COULD NOT BE PERFORMED AS THE DEVICES WERE NOT PROPERLY IDENTIFIED. COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED AS THE DEVICES WERE NOT PROPERLY IDENTIFIED. THE ROOT CAUSES COULD NOT BE DETERMINED WITH THE LIMITED INFO PROVIDED.
Description of Event or Problem
IT WAS REPORTED THAT THE SUBJECT IS IN THE (B)(4) CLINICAL STUDY. THE SUBJECT UNDERWENT A REVISION OF THEIR PRIMARY STRYKER KNEE SYSTEM ON (B)(6) 2012 DUE TO ASEPTIC FAILURE OF THE KNEE.
Remedial action
- Other