Arthrex® AR-9502F-42CPCRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867234253), received between Aug 5, 2020 and Nov 24, 2025 — classified as 2 injuries, 3 malfunctions.

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

• MalfunctionNov 24, 2025Positioning Failure; Positioning Failure

  ON 11/3/2025, IT WAS REPORTED VIA EMAIL BY A SALES REPRESENTATIVE THAT AN AR-9503L-06 ARTHREX UNIVERS REVERS HUMERAL INSERT LARGE WAS NOT SEATING PROPERLY IN A 42 NEUTRAL SUTURECUP. THE SURGEON NOTED THAT THE TAPER DID NOT APPEAR TO BE ENGAGING THE SUTURECUP CORRECTLY. AFTER FLUSHING BOTH THE SUTURECUP AND THE HUMERAL INSERT TO RULE OUT DEBRIS INTERFERENCE, THE ISSUE PERSISTED. THE SURGEON THEN OPENED A NEW UNIVERS REVERS HUMERAL INSERT, WHICH SEATED PROPERLY WITHOUT ISSUE. THIS WAS DISCOVERED DURING AN RTSA PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 11/11/2025: ON (B)(6) 2025, DURING AN RTSA PROCEDURE, THE SURGEON ENCOUNTERED AN ISSUE WITH SEATING AN AR-9503L-06 ARTHREX UNIVERS REVERS HUMERAL INSERT (LARGE) INTO AN AR-9502F-42CPC ARTHREX UNIVERS REVERS SUTURE CUP, 42 (NEUTRAL). THE TAPER ON THE INSERT DID NOT APPEAR TO ENGAGE PROPERLY WITH THE SUTURE CUP, AND THE TAPER WAS CONFIRMED TO BE PART OF THE INSERT. THIS OCCURRED DURING THE FINAL IMPLANTATION INSIDE THE PATIENT. NO COMPONENT FRACTURED INSIDE THE PATIENT. TO COMPLETE THE CASE, THE SURGEON ELECTED TO USE A SPACER AND A +3 POLYETHYLENE INSERT, SUSPECTING THE TAPER ON THE CUP MIGHT HAVE CONTRIBUTED TO TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23632161 ↗
• MalfunctionMar 13, 2025Positioning Failure; Positioning Failure

  ON 2/21/2025, 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 21596930 ↗
• MalfunctionMar 12, 2025Positioning Failure; Positioning Failure

  ADDITIONAL INFORMATION WAS RECEIVED ON 3/6/2025: THE PART NUMBER FOR THE SUTURECUP IS AN AR-9502F-42CPC. NOTHING BROKE INSIDE THE PATIENT. THE CASE WAS COMPLETED BY USING AN AR-9503L-06 ARTHREX UNIVERS REVERS HUMERAL INSERT WITH THE SAME AR-9502F-42CPC ARTHREX UNIVERS REVERS SUTURECUP. THE CASE WAS NOT DELAYED, AND ADDITIONAL ANESTHESIA WAS NOT NEEDED.

  Patient problems: Insufficient Information

  MAUDE report 21583115 ↗
• 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 21536465 ↗
• InjuryAug 5, 2020Appropriate Device Problem Term/Code Not Available

  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 10366813 ↗