HMRS ROT HINGE BUMPER 0 DEG

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. IN ORDER TO GIVE STABILITY TO THE BUMPER, THE SURGEON DECIDED TO PUT SOME CEMENT INSITE THE HOLE OF TRC."

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.