UNKNOWN STRYKER TIBIAL COMPONENT
Received Nov 29, 2012 · Event occurred May 28, 2012
Report 2249697-2012-02451 · MDR key 2858557
Device
Generic name
Implant
Manufacturer
Stryker Orthopaedics MahwahModel number
NACatalog number
UNK
Lot number
UNK
Product problems
- Device Slipped
- Naturally Worn
Patient
75 YR
- Pain
- No Code Available
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE SUBJECT IS ENROLLED IN THE (B)(6) STUDY. THE SUBJECT UNDERWENT A REVISION OF THEIR PRIMARY STRYKER KNEE SYSTEM, ON (B)(6) 2012 DUE TO ASEPTIC FAILURE OF THE KNEE.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT #UNK, LOT #UNK DESCRIPTION: UNKNOWN STRYKER FEMORAL COMPONENT. CAT #UNK, LOT #UNK DESCRIPTION: UNKNOWN FEMORAL COMPONENT. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S INFECTION.
Remedial action
- Other