HMRS ROT HINGE BUMPER 0 DEG
Received Dec 8, 2011 · Event occurred Nov 19, 2011
Report 9610726-2011-00414 · MDR key 2419345
Device
Generic name
Implant
Manufacturer
Stryker Orthopaedics LimerickModel number
NACatalog number
64832150
Lot number
LCL298
Product problems
- Device Operates Differently Than Expected
Patient
UNK
- No Information
Narrative
Additional Manufacturer Narrative
AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. IF ADD'L INFO BECOMES AVAILABLE, IT 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
THE SALES REP REPORTED THAT PROF (B)(6) NOTED THAT DURING THE PROCEDURE WITH HMRS ROTATING HINGE REVISION SURGERY, AFTER THE REPLACEMENT OF POLY COMPONENTS OF TRC, THE BUMPER DIDN'T FIT PERFECTLY WITH THE TRC AS USUAL. THE SURGEON USED THE CEMENT TO GIVE STABILITY TO THE BUMPER."
Remedial action
- Other