Arthrex® AR-9502-42ARCARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867230392), received between Aug 5, 2020 and Mar 13, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2025Positioning Failure; Positioning Failure

  ON (B)(6)2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT A PATIENT UNDERWENT REVISION SURGERY. THE PATIENT HAD IMPLANTS FROM ANOTHER MANUFACTURER AND THOSE IMPLANTS WERE ATTEMPTED TO BE PAIRED WITH AN AR-9502F-42CPC ARTHREX UNIVERS REVERS SUTURE CUP AND A 9 MM STEM. THE STEM AND CUP WERE WELL FIXED WHILE THE BASEPLATE AND GLENOID COMPONENTS FROM ANOTHER MANUFACTURER HAD BEEN LEVERED OUT. BECAUSE THE STEM WAS WELL FIXED THE SURGEON DECIDED TO CONVERT IT TO A CA HEAD TO GIVE THE PATIENT A MINIMAL AMOUNT OF MOVEMENT. THE POLY WAS REMOVED, AND CUP WAS CLEANED THEN A 42 INSERT WAS OPENED IN WHICH THE SURGEON COULD NOT GET THE CA INSERT TO A COUPLE WITH THE AR-9502F-42CPC ARTHREX UNIVERS REVERS SUTURE CUP. A NEW AR-9502F-42CPC ARTHREX UNIVERS REVERS SUTURE CUP WAS OPENED AND WAS ATTEMPTED TO BE INSERTED AGAIN WITH NO AVAIL. A NEW INSERT WAS OPENED, WHICH PHYSICALLY, IT LOOKED DIFFERENT, IT WAS SLIGHTLY BIGGER AND WOULD NOT ALLOW TO SEAT INTO THE CUP. FINALLY, A 93 CUP OF A 39 INSERT WAS ABLE TO WORK. THIS WAS DISCOVERED DURING A REVISION REVERS SURGERY ON (B)(6) 2025. ADDITIONAL INFORMATION REQUESTED ON 2/28/2025.

  Patient problems: Insufficient Information

  MAUDE report 21596584 ↗
• 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 21536165 ↗
• 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 21536150 ↗
• MalfunctionSep 18, 2024Fitting Problem; Fitting Problem

  ON 09/9/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9502-42ARCA UNIVERS REVERS CA HUMERAL HEAD ADAPTER POOPED OFF WHEN THE HUMERAL HEAD WAS PUT ON. THE HUMERAL HEAD WAS REMOVED FROM THE ADAPTER, AND THEN THE SURGEON ATTEMPTED TO INSERT IT AGAIN. IT APPEARED THAT THE ADAPTER WAS NOT SITTING WITH A REALLY GOOD SEAL ON THE SUTURE CUP. THE SURGEON ATTEMPTED MULTIPLE TIMES AGAIN WITHOUT SUCCESS. OVERALL, THE CASE WAS DELAYED FORTY-FIVE MINUTES WITH ADDITIONAL ANESTHESIA, WHILE WAITING FOR ANOTHER AR-9502-42ARCA UNIVERS REVERS CA HUMERAL HEAD ADAPTER TO BE BROUGHT INTO THE OPERATING ROOM. THE NEW ADAPTER WORKED PERFECTLY WITHOUT ANY ISSUES. THIS WAS DISCOVERED DURING A HEMI ARTHROPLASTY PROCEDURE ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20248530 ↗
• InjuryAug 5, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UNIVERS REVERS TOTAL SHOULDER PROCEDURE (B)(6) 2019. THE PATIENT WAS EXPERIENCING POST OP PAIN AND AN INFECTION. THE ORIGINAL SURGEON PERFORMED A SECOND SURGERY AT THE SAME FACILITY (B)(6) 2020. DURING THE SECOND SURGERY THE FOLLOWING ORIGINAL ARTHREX PRODUCTS WERE EXPLANTED: AR-9501-06P, UNIVERS REVERS STEM, LOT 18.01910. AR-9502F-42CPC, UNIVERS REVERS SUTURE CUP, LOT 170095605. AR-9502-42ARCA, REVERS ADAPTER ASSEMBLY, LOT 241624. AR-9556-22RCA, REVERS CA HUMERAL HEAD, LOT 10165385. THE EXPLANTED DEVICES WILL BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION OBTAINED 7/22/20: THE GLENOID IMPLANTS FROM THE ORIGINAL PROCEDURE WERE LEFT IN THE PATIENT. THE ONLY DEVICES EXPLANTED WERE THE ABOVE LISTED IMPLANTS. THE SPECIFIC TYPE OF INFECTION OR ANY CULTURE RESULTS ARE NOT BEING PROVIDED TO THE SALES REP.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 10366820 ↗