InjuryHSH
HMRS ROT HINGE TIB ROT COMP
Received Jul 18, 2011 · Event occurred Jun 29, 2011
Report 9610726-2011-00259 · MDR key 2171346
Device
Generic name
Implant
Manufacturer
Stryker Orthopaedics LimerickModel number
NACatalog number
6483-2-250
Lot number
UNK
Product problems
- Break
Patient
UNK
- No Code Available
Narrative
Additional Manufacturer Narrative
WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THE SUBJECT DEVICE IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S.
Description of Event or Problem
IT WAS REPORTED THAT A HMRS ROT HINGE TIB ROT COMP IMPLANTED ABOUT 10 YEARS AGO WAS BROKEN ON (B)(6) 2011. THE REVISION SURGERY WILL BE PERFORMED ON (B)(6) 2011.
Remedial action
- Other