Arthrex® AR-9503S-03CRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867061309), received between May 20, 2020 and Sep 17, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 16, 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.

• MalfunctionSep 17, 2026Defective Device

  On (b)(6)2026, it was reported by a sales representative via (b)(6) that an AR-9503S-03C Arthrex UNIVERS REVERS Humeral Insert was found to be defective during a procedure. No patient impact was reported, as a second implant was available and used to complete the procedure. No further information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50802725 ↗
• InjurySep 2, 2020Break; Corroded; Unstable; Positioning Problem

  IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE AN INITIAL REVISION SURGERY ON (B)(6) 2018 DURING WHICH THE FOLLOWING DEVICES WERE IMPLANTED: AR-9120-01 (LOT 170115215), AR-9145-36 (LOT 170037012), AR-9145-30 (LOT 170057712), AR-9504S-04 (LOT 170091414), AR-9555-09 (LOT 2501367202), AR-9503S-03C (LOT 2501374603), AR-9165-25 (LOT 2501357504). THE (B)(6) 2018 PROCEDURE WAS A REVISION OF ARTHREX PRODUCTS BECAUSE THE PATIENT HAD GLENOID INSTABILITY DUE TO BASEPLATE PLACEMENT ON THE PRIMARY. IT IS UNKNOWN IF THE 2018 REVISION WAS EVER REPORTED TO ARTHREX AS NO DETAILS FROM THE ORIGINAL SURGERY ARE KNOWN TO SEARCH/MATCH PART NUMBERS. THE IMPLANTS PUT IN ON (B)(6) 2018 WERE DONE SO IN A COMPROMISED GLENOID WITH POOR BONE QUALITY. THE PERIPHERAL SCREWS BROKE AND LED TO BASEPLATE FAILURE. THE GLENOSPHERE REMAINED ENGAGED IN THE BASEPLATE. THERE WAS SIGNIFICANT CORROSION OF THE HUMERAL POLY INSERT. THE GLENOID COMPONENTS FAILED NEARLY TWO YEARS AGO BUT THE PATIENT WAITED UNTIL (B)(6) 2020 TO HAVE A REVISION SURGERY. THE SALES REPRESENTATIVE REPORTED THAT THE SURGEON ATTRIBUTED THE FAILURE TO PUTTING THE BASEPLATE ON HER ORIGINAL REVERSE PROCEDURE TOO SUPERIOR ON THE FACE OF THE GLENOID WITH S

  Patient problems: No Code Available

  MAUDE report 10482848 ↗
• InjuryMay 20, 2020Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL REVERSE SHOULDER PROCEDURE WITH MODIFIED GLENOID SYSTEM IN (B)(6) 2019. THE PATIENT HAD RECENTLY UNDERGONE A REVISION PROCEDURE ON (B)(6) 2020 DUE TO PAIN AND CONSTRUCT DISLOCATION. AT THE (B)(6) REVISION, THE HUMERAL INSERT WAS EXPLANTED AND A SPACER AND NEW INSERT WERE IMPLANTED. THE (B)(6) 2020 REVISION WAS REPORTED UNDER CASE (B)(4). ON (B)(6) 2020, THE PATIENT HAD A THIRD PROCEDURE DUE TO NEUROPATHY; THE FOLLOWING DEVICES WERE ALL EXPLANTED: IMPLANTS: AR-9503S-03C (LOT 19.00210), AR-9555-06 (LOT 16.01037), AR-9564-2436-LAT (LOT 19.00689) AND AR-9560-24 (LOT 02191932) AND 4 SCREWS: AR-9563-16, AR-9563-28 (QTY2) AND AR-9563-20 TO COMPLETE THE PROCEDURE THE SURGEON IMPLANTED THE FOLLOWING DEVICES: AR-9502-36ARCA (LOT 18.00755) AND AR-9550-19RCA (LOT 10071328).

  Patient problems: Joint Dislocation; Neuropathy; Pain

  MAUDE report 10074335 ↗