PERFORM COCR HUMERAL HEAD 43X16

Additional Manufacturer Narrative

A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

THE PATIENT SUSTAINED A PROXIMAL HUMERUS FRACTURE THAT WAS TREATED WITH TUBEROSITY REPAIR AND HEMIARTHROPLASTY. AT THE TIME OF THE PROCEDURE, THE ROTATOR CUFF WAS CONFIRMED TO BE INTACT. FOLLOWING SURGERY, THE PATIENT WAS REPORTEDLY NON-COMPLIANT WITH SLING USE AND NON-WEIGHT-BEARING RESTRICTIONS, RESULTING IN FAILURE OF THE FRACTURE REPAIR. THE PATIENT DID NOT RETURN FOR FOLLOW-UP UNTIL A LATER DATE, AT WHICH TIME CONCERNS REGARDING THE OUTCOME OF THE REPAIR WERE IDENTIFIED. FOLLOWING POSITIVE CULTURE RESULTS, THE PATIENT REQUESTED REMOVAL OF THE HEMIARTHROPLASTY AND PLACEMENT OF AN ANTIBIOTIC SPACER. THE SURGEON EXPLAINED THE ANTICIPATED FUNCTIONAL LIMITATIONS ASSOCIATED WITH REMOVAL OF THE IMPLANT; HOWEVER, THE PATIENT ELECTED TO PROCEED WITH EXPLANTATION. THE HEMIARTHROPLASTY WAS REMOVED AND REPLACED WITH AN ANTIBIOTIC SPACER.