InjuryHSH
HMRS ROT HINGE AXLE
Received Feb 24, 2012 · Event occurred Feb 3, 2012
Report 9610726-2012-00061 · MDR key 2471023
Device
Generic name
Implant
Manufacturer
Stryker Orthopaedics LimerickModel number
NACatalog number
6483-1-350
Lot number
LZDFY1
Product problems
- Insufficient Device Problem Information
Patient
39 YR
- No Code Available
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PHARMACIST AT THE HOSPITAL REPORTED THE FOLLOWING EVENT, "THE PT WAS PROGRESSIVELY A GENU RECURVATUM WITH LAXITY. IT WAS DECIDED TO PROCEED TO A PARTIAL REVISION SURGERY OF THE PROSTHESIS."
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.
Remedial action
- Other