Arthrex® AR-9502-39ARCARecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867230385), received between Aug 24, 2020 and Dec 11, 2025 — classified as 3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING THE SHOULDER REPLACEMENT SURGERY, THE DEVICE CAN ONLY BE LOCKED INTO THE SUTURECUP WITH GREAT DIFFICULTY AND DOES NOT LOCK PROPERLY. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE WAS USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23776821 ↗
• MalfunctionNov 5, 2025Positioning Failure; Positioning Failure

  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 IN THE ORIGINAL SURGERY INCLUDE, AR-9503M-03 ARTHREX UNIVERS REVERS HUMERAL INSERT MEDIUM / 39 / +3, AR-9502F-39CPC ARTHREX UNIVERS REVERS SUTURE CUP, 39 (NEUTRAL), AR-9562-28NL UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, NON-LOCKING 4.5 X 28 MM, AR-9563-20 UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, LOCKING 5.5 X 20 MM, AR-9563-28 UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, LOCKING 5.5 X 28 MM, AR-9564-2439-LAT ARTHREX UNI

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

  MAUDE report 23477670 ↗
• MalfunctionNov 5, 2025Positioning Failure; Positioning Failure

  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 IN THE ORIGINAL SURGERY INCLUDE, AR-9503M-03 ARTHREX UNIVERS REVERS HUMERAL INSERT MEDIUM / 39 / +3, AR-9502F-39CPC ARTHREX UNIVERS REVERS SUTURE CUP, 39 (NEUTRAL), AR-9562-28NL UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, NON-LOCKING 4.5 X 28 MM, AR-9563-20 UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, LOCKING 5.5 X 20 MM, AR-9563-28 UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, LOCKING 5.5 X 28 MM, AR-9564-2439-LAT ARTHREX UNI

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

  MAUDE report 23477353 ↗
• InjuryMar 6, 2025Positioning Failure; Positioning Failure

  ON (B)(6) 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 21536220 ↗
• InjuryMay 10, 2024Connection Problem; Connection Problem

  ON 6/23/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT DURING A REVISION PROCEDURE, BOTH THE AR-9502-29ARCA, REVERS 39MM CA ADAPTER ASSEMBLY AND, AR-9550-29RCA, REVERS CA HUMERAL HEAD, 50/19, WERE HAVING ISSUES SEATING. THE SURGEON HAD THEM IN THE SUTURE CUP AND THEN AFTER TRIAL REDUCTION, THEY WERE AUGMENTING THE SUBS CAP AND DID AN INTERNAL ROTATION. THE ADAPTOR AND HEAD, BOTH, POPPED OUT OF THE CUP. THE HEAD BECAME STUCK ON THE POST AND THE ADAPTOR WOULD NOT SIT IN THE CUP. IN ORDER TO BE SAFE IT WAS AGREED THAT A NEW IMPLANT BE USED TO COMPLETE THE CASE. THE SURGEON HAD NO ISSUES AFTER SWAPPING OUT THE IMPLANTS, HOWEVER, IT DID ADD TIME TO THE CASE. THE REVISION WAS A CONVERSION FROM A REVERS TOTAL SHOULDER PROCEDURE TO A HEMI DUE TO THE MGS BEING LOOSE AND NOT HOLDING IN THE GLENOID. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19290662 ↗
• InjuryAug 24, 2020Microbial Contamination of Device

  AN ARTHREX EMPLOYEE HAS REPORTED THAT A PATIENT DEVELOPED AN INFECTION IN THE SURGICAL AREA. THE PROSTHESIS WAS EXCHANGED. IT WAS FURTHER REPORTED THAT THE CUSTOMER IS LOOKING FOR GERMS ON THE PROSTHESIS. NO FURTHER INFORMATION RECEIVED. UPDATE 30-JULY-2020: FURTHER INFORMATION WERE PROVIDED THAT THE INITIAL SURGERY WAS PERFORMED IN (B)(6) 2019. THE REPORTED PRODUCT WAS REPLACED DURING THE REVISION. THE INFECTION WAS IDENTIFIED ON (B)(6) AND THE REVISION WAS PERFORMED ON (B)(6) 2020.

  Patient problems: Unspecified Infection

  MAUDE report 10443157 ↗