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

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867234277), received between Jul 6, 2023 and Apr 4, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Biocompatibility” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 4, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON 3/4/2025, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY SUFFERED LOOSENING OF HUMERAL SIDE IMPLANTS. THE PATIENT SUFFERED AN INJURY AFTER LIFTING A FIVE-POUND BOX. THE X-RAYS INDICATED A SMALL NON-DISPLACED FRACTURE AND LOOSE HUMERAL COMPONENTS. THE PATIENT UNDERWENT A REVISION RSA AND OFIF PROCEDURE ON (B)(6) 2022. THIS EVENT WAS INDICATED AS UNRELATED TO THE UNIVERSE REVERSE SYSTEM IMPLANTED ON (B)(6) 2020. NO FURTHER INFORMATION WAS REPORTED. ADDITIONAL INFORMATION RECEIVED ON 3/19/2025: DURING THE REVISION SURGERY ON (B)(6) 2022 AN AR-9564-2842-LAT ARTHREX UNIVERS REVERS GLENOSPHERE, AN AR-9563-16 UNIVERS REVERS PERIPHERAL SCREW, TWO AR-9563-24 UNIVERS REVERS PERIPHERAL SCREW, AN AR-9562-32NL UNIVERS REVERS PERIPHERAL SCREW, AN AR-9502F-42RCPC ARTHREX UNIVERS REVERS SUTURE CUP, AN AR-9501-11P ARTHREX UNIVERS REVERS HUMERAL STEM, AN AR-9550-15 ARTHREX UNIVERS REVERS SPACER, AND AN AR-9503L-06C ARTHREX UNIVERS REVERS HUMERAL INSERT WAS REMOVED. THE CASE WAS COMPLETED WITH NEW ARTHREX UNIVERS REVERS IMPLANTS.

  Patient problems: Bone Fracture(s)

  MAUDE report 21774134 ↗
• InjuryOct 20, 2023Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT AFTER AN INITIAL SURGERY ON (B)(6) 2023 THE PATIENT DEVELOPED A SEVERE INFECTION WHICH AFFECTED THE PATIENT FOR 6 MONTHS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO REMOVE THE INVOLVED IMPLANTS. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Unspecified Infection

  MAUDE report 17977007 ↗
• InjuryJul 6, 2023Break; Use of Device Problem; Break; Use of Device Problem

  ON 06/16/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9512 STEM / CUP EXTRACTION ADAPTER HANDLE WAS STRIPPED, AND AN AR-1999HH RATCHETING HANDLE BROKE. THIS OCCURRED DURING AN REVERSE TOTAL SHOULDER ARTHROPLASTY REVISION CASE ON (B)(6) 2023, WHILE TAKING THE SUTURE-CUP OUT OF THE AR-9512 IT STRIPPED AND COULD NOT TWIST INTO THE SUTURE-CUP. WHILE TAKING THE BASEPLATE OUT THE AR-1999HH BROKE AND DID NOT RATCHET APPROPRIATELY. ANOTHER OF THE SAME PART WAS USED TO CONTINUE. THE CASE CARRIED ON AND WAS COMPLETED SUCCESSFULLY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION WAS PROVIDED ON 06/26/2023, IT WAS REPORTED THAT ON(B)(6) 2021 THE PATIENT UNDERWENT A REVERSE TOTAL SHOULDER ARTHROPLASTY PROCEDURE IN WHICH AR-9502F-42RCPC SUTURE CUP, AN AR-9503L-03C HUMERAL INSERT, AND AN AR-9550-09 UNIVERS REVERS¿ SPACER WERE IMPLANTED. ON (B)(6) 2023 THE PATIENT UNDERWENT A REVERSE TOTAL SHOULDER ARTHROPLASTY REVISION PROCEDURE WHERE THE AR-9502F-39RCPC, AND AR-9503M-06 WERE EXPLANTED. THE CASE WAS COMPLETED USING OTHER PARTS.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17273076 ↗