Arthrex® AR-9502F-39CPCRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867234222), received between Apr 28, 2023 and Jun 3, 2026 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2026Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 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 INDIC

  Patient problems: Unspecified Infection

  MAUDE report 25375322 ↗
• InjuryApr 16, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT AFTER AN INVERSE SHOULDER PROSTHESIS SURGERY ON (B)(6) 2026 THE PATIENT HAS DEVELOPED AN INFECTION. ON (B)(6) 2026 ALL IMPLANTS WERE REMOVED AND THE AFFECTED AREAS WERE CLEANSED AND TREATED. A NEW PROSTHESIS WILL BE IMPLANTED IN 6-8 WEEKS.

  Patient problems: Unspecified Infection

  MAUDE report 24903226 ↗
• InjuryFeb 16, 2026Break; Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE SALES REPRESENTATIVE ON 11-FEB-2026: ON 11-FEB-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT A PATIENT UNDERWENT A REVISION REVERSE TOTAL SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2026 DUE TO A FAILED BASEPLATE. THE SURGEON WHO PERFORMED THE REVISION PROCEDURE ASSUMED THAT THE BASEPLATE WAS NEVER INCORPORATED BECAUSE OF MICROMOTION, POSSIBLY DUE TO THE SHORT LENGTH OF THE SCREWS AND THE BASEPLATE BEING PLACED TOO SUPERIORLY. THIS MICROMOTION SUBSEQUENTLY RESULTED IN THE INFERIOR SCREW BREAKING OFF. A SUCCESSFUL REVISION REVERSE SHOULDER SURGERY WAS PERFORMED AFTER ALL OTHER COMPONENTS WERE REMOVED, EXCEPT FOR THE OTHER HALF OF THE BROKEN SCREW. A DIFFERENT SURGEON PERFORMED THE ORIGINAL SURGERY. THE EXPLANTED PRODUCTS DURING THE REVISION REVERSE TOTAL SHOULDER ARTHROPLASTY PROCEDURE INCLUDE AR-9503M-03 ARTHREX UNIVERS REVERS HUMERAL INSERT MEDIUM / 39 / +3, AR-9502F-39CPC ARTHREX UNIVERS REVERS SUTURE CUP, 39 (NEUTRAL), AR-9501-10S UNIVERS REVERS APEX HUMERAL STEM SIZE 10, AR-9580-2420 UNIVERS REVERS MODULAR GLENOID SYSTEM AUGMENTED BASE PLATE 24 MM, 20° FULL, OBLIQUE, AR-9563-20 UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL S

  Patient problems: Discomfort; Pain

  MAUDE report 24345490 ↗
• InjuryJan 5, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT THE INVERS SHOULDER PROTHESIS WAS INITIALLY IMPLANTED ON (B)(6) 2020. A CRASH ON (B)(6) 2020, CAUSED A PERIPROSTHETIC FRACTURE, WHICH WAS TREATED CONSERVATIVELY. THE FRACTURE SUBSEQUENTLY HEALED. THE LAST IMAGES TAKEN ON (B)(6) 2022, SHOWED THAT THE IMPLANT WAS IN THE CORRECT POSITION. THE X-RAYS TAKEN ON (B)(6) 2025, SHOWED A FRACTURE BETWEEN THE CUP AND THE SHAFT. THE IMPLANT WAS REMOVED ON (B)(6) 2025.

  Patient problems: Bone Fracture(s)

  MAUDE report 23956148 ↗
• InjuryNov 18, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 10/28/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT TWO AR-9502-39ARCA UNIVERS REVERS CA HUMERAL HEAD ADAPTER 39 COMPONENTS COULD NOT BE SECURED DURING SURGERY. THE PROCEDURE WAS A REVISION REVERSE SHOULDER ARTHROPLASTY ON (B)(6) 2025. DURING THE OPERATION, THE ORIGINAL LINER WAS REMOVED FROM THE PATIENT. WHEN ATTEMPTING TO PLACE BOTH AR-9502-39ARCA UNIVERS REVERS CA HUMERAL HEAD ADAPTER 39 INTO THE 39 SUTURE CUP, NEITHER ADAPTER WOULD SNAP INTO PLACE. ADDITIONAL INFORMATION WAS RECEIVED ON 11/03/2025: THE PATIENT UNDERWENT A REVISION REVERSE SHOULDER ARTHROPLASTY ON (B)(6) 2025 FOLLOWING A FALL-RELATED INCIDENT. DURING THE PROCEDURE, ATTEMPTS TO IMPLANT TWO COMPONENTS, AR-9502-39ARCA UNIVERS REVERS CA HUMERAL HEAD ADAPTER 39 AND AR-9556-22RCA UNIVERS REVERS CA HUMERAL HEAD 56/22, WERE UNSUCCESSFUL AS THEY COULD NOT BE SECURED. THIS ISSUE EXTENDED THE SURGICAL TIME BY APPROXIMATELY 30 MINUTES. AS PART OF THE REVISION, ALL IMPLANTS FROM THE ORIGINAL REVERSE SHOULDER ARTHROPLASTY PERFORMED IN (B)(6) 2023 WERE EXPLANTED. THE ORIGINAL SURGERY WAS PERFORMED AT THE SAME FACILITY BY THE SAME SURGEON AND HAD NO REPORTED INTRAOPERATIVE COMPLICATIONS. THE ARTHREX PRODUCTS IMPLANTED

  Patient problems: Insufficient Information

  MAUDE report 23586428 ↗
• InjuryMar 6, 2025Positioning Failure; Positioning Failure

  ON 02/14/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THE FOLLOWING ARTHREX PARTS (QTY. 2) OF AN AR-9502-42ARCA UNIVERS REVERS CA HUMERAL HEAD ADAPTER 42, AR-9502-39ARCA UNIVERS REVERS CA HUMERAL HEAD ADAPTER 39, AR-9556-22RCA UNIVERS REVERS CA HUMERAL HEAD 56/22, AR-9502F-42CPC ARTHREX UNIVERS REVERS SUTURE CUP, 42, AR-9502F-39CPC ARTHREX UNIVERS REVERS SUTURE CUP, 39 (NEUTRAL), AR-9501-10P ARTHREX UNIVERS REVERS HUMERAL STEM, SIZE 10 WERE UNSUCCESSFUL IN SEATING THE 42 ADAPTER INTO THE 42 CUP. A 39 ADAPTER AND A 39 CUP WERE ALSO ATTEMPTED BUT UNSUCCESSFUL IN PROPERLY SEATING. NOTHING BROKE INSIDE THE PATIENT. THE PROCEDURE WAS ABORTED. THIS WAS DISCOVERED DURING A REVISION REVERSE SHOULDER PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21536488 ↗
• MalfunctionApr 28, 2023Decoupling; Loosening of Implant Not Related to Bone-Ingrowth; Decoupling; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT 6 MONTHS AFTER THE INITIAL SURGERY THE IMPLANTED CUB BECAME DETACHED FROM THE SHAFT. A REVISION UNIVERSE REVERSE SURGERY WAS THEREFORE PERFORMED AND A NEW CUP WITH THE SAME PART NUMBER WAS IMPLANTED WITH AN 155° INCLINATION TO RESOLVE THE ISSUE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 16838563 ↗