UNIVERS REVERS HUMERAL STEM, SIZE 6

Additional Manufacturer Narrative

INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

Description of Event or Problem

ON 19-MAY-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN ARTHREX REVERSE TOTAL SHOULDER ARTHROPLASTY (RTSA) SYSTEM WAS EXPLANTED DURING A REVISION PROCEDURE. UPON EXAMINATION OF THE REMOVED HUMERAL COMPONENTS, THE AR-9502F-39CPC ARTHREX UNIVERS REVERSE SUTURE CUP, 39 (NEUTRAL), WAS OBSERVED TO BE LOOSE FROM THE AR-9501-06P ARTHREX UNIVERS REVERSE HUMERAL STEM, SIZE 6, WHILE THE HUMERAL STEM REMAINED FIRMLY SEATED IN THE HUMERAL CANAL WITHOUT EVIDENCE OF LOOSENING. ADDITIONALLY, THE FRONT SURFACE OF THE BASEPLATE AND THE BACKSIDE OF THE AR-9564-2439-LAT GLENOSPHERE 39 +4 LAT/24 WERE NOTED TO BE COVERED WITH A WHITE/BEIGE SUBSTANCE. THERE WAS A REPORTED CONCERN FOR A POSSIBLE ASSOCIATED INFECTION. ALL ARTHREX IMPLANTS, INCLUDING THE GLENOSPHERE AND THE POLYETHYLENE COMPONENT, AR-9503M-06 HUMERAL INSERT, M/39/+6, WERE REMOVED. THE SURGICAL SITE WAS IRRIGATED, AND A TEMPORARY SPACER WAS PLACED. ADDITIONAL INFORMATION WAS RECEIVED ON 28-MAY-2026: THE REVISION PROCEDURE WAS PERFORMED DUE TO SUSPECTED IMPLANT LOOSENING AND INFECTION. THE ONSET OF SYMPTOMS FOLLOWING THE INITIAL SURGERY IS UNKNOWN; HOWEVER, THE PATIENT REPORTED PAIN PRIOR TO REVISION. PRE-OPERATIVE ASSESSMENT INDICATED CONCERN FOR INFECTION, INCLUDING ELEVATED WHITE BLOOD CELL COUNT AND IMAGING SUGGESTIVE OF IMPLANT LOOSENING. THE FOLLOWING ARTHREX IMPLANTS WERE ALSO REMOVED DURING THE PROCEDURE INCLUDE: AR-9582-30 MODULAR POST FOR AUGMENTED MGS BASEPLATE 30 MM, AR-9580-2410 BASEPLATE 24 MM 10° FULL OBLIQUE, TWO AR-9563-24 PERIPHERAL SCREWS (5.5 X 24 MM), AND ONE AR-9563-20 PERIPHERAL SCREW (5.5 X 20 MM). DURING THE PROCEDURE, INTRAOPERATIVE CULTURES AND SPECIMENS WERE COLLECTED; RESULTS ARE PENDING. A WHITE/BEIGE SUBSTANCE OBSERVED ON THE IMPLANTS WAS ALSO SENT FOR ANALYSIS, WITH RESULTS PENDING. ASIDE FROM THE REPORTED SUTURECUP LOOSENING, NO OTHER IMPLANTS WERE IDENTIFIED AS ABNORMAL, AND NO VISIBLE SIGNS OF WEAR OR CORROSION WERE NOTED. THE ORIGINAL REVERSE TOTAL SHOULDER ARTHROPLASTY WAS PERFORMED ON (B)(6) 2023 AT A DIFFERENT FACILITY BY A DIFFERENT SURGEON. THE REVISION PROCEDURE WAS COMPLETED WITHOUT IMMEDIATE COMPLICATIONS. NO ARTHREX PRODUCTS WERE IMPLANTED DURING THE REVISION. POSTOPERATIVELY, THE PATIENT RECEIVED AN ANTIBIOTIC SPACER. A SUBSEQUENT PROCEDURE IS PLANNED FOR SPACER REMOVAL, AT WHICH TIME A REVISION REVERSE TOTAL SHOULDER ARTHROPLASTY IS INTENDED. ADDITIONAL SURGERY IS ANTICIPATED.