Arthrex® AR-9503-3633-3CRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867296619), received between May 24, 2021 and Jul 25, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Naturally Worn” (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.

• InjuryJul 25, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2024, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY UNDERWENT REVISION SURGERY FOR UNKNOWN REASONS. IMAGES WERE TAKEN ON (B)(6) 2024, SHOWING THE PATIENT NO LONGER HAD THE ORIGINAL ARTHREX IMPLANTS FROM THE ORIGINAL SURGERY ON (B)(6) 2022. UPON FURTHER REVIEW, IT WAS DISCOVERED THAT THE PATIENT WAS REVISED ON 2022 AT AN OUTSIDE FACILITY. AN AR-9501-09S UNIVERS REVERS APEX HUMERAL STEM SIZE 9, AN AR-9502F-36RCPC ARTHREX UNIVERS REVERS SUTURE CUP 36 MM, AN AR-9582-20 MODULAR POST FOR AUGMENTED MGS BASEPLATE 20 MM, AN AR-9580-2420-2 UNIVERS REVERS MODULAR GLENOID SYSTEM, AUGMENTED BASEPLATE 24 MM +2, 20 DEGREE FULL, TWO AR-9562-24NL UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, NON-LOCKING 4.5 X 24 MM, AN AR-9503-3633-3C UNIVERS REVERS MODULAR GLENOID SYSTEM CONSTRAINED COMBO HUMERAL INSERT 36 +3C / 33, AN AR-9564-2433 ARTHREX UNIVERS REVERS MODULAR GLENOID SYSTEM GLENOSPHERE 33/24, AND TWO AR-9563-24 UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, LOCKING 5.5 X 24 MM, WERE EXPLANTED DURING THE REVISION SURGERY ON (B)(6) 2022. NO OTHER INFORMATION OTHER THAN THE DATE OF SURGERY WAS AVAILABLE FOR

  Patient problems: Insufficient Information

  MAUDE report 19829638 ↗
• InjuryMay 23, 2022Naturally Worn; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A PATIENT HAD A LEFT SHOULDER RTSA ON (B)(6) 2020. ON (B)(6) 2022, PATIENT UNDERWENT A REVISION SURGERY DUE TO CHRONIC INSTABILITY OF THE GLENOID, WHICH APPEARED TO BE WORN OUT. HOWEVER, SALES REPRESENTATIVE COULD NOT CONFIRM IF ANY OF THE ARTHREX IMPLANTED DEVICES HAD BROKEN. DURING THE REVISION SURGERY ON (B)(6) 2022, AN AR-9560-24 UNIVERS REVERS BASEPLATE, AR-9561-25S UNIVERS REVERS CENTRAL SCREW, AN AR-9563-16 UNIVERS REVERS PERIPHERAL SCREW, AN AR-9563-24 UNIVERS REVERS PERIPHERAL LOCKING SCREW, AN AR-9564-2433-LAT UNIVERS REVERS GLENOSPHERE, AN AR-9502F-36CPC UNIVERS REVERS SUTURE CUP, AND AN AR-9503-3633-3C UNIVERS REVERS CONSTRAINED COMBO HUMERAL INSERT WERE REMOVED. SURGEON DID NOT REMOVE THE UNIVERS REVERS STEM THAT WAS IMPLANTED DURING ORIGINAL PROCEDURE ON (B)(6) 2022. TO COMPLETE THE REVISION SURGERY, AN AR-9502-36ARCA UNIVERS REVERS CA HUMERAL HEAD ADAPTER AND AN AR-9550-19RCA UNIVERS REVERS CA HUMERAL HEAD WERE IMPLANTED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 14468977 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A REVERSE SHOULDER CASE DONE IN (B)(6) 2020. DUE TO INFECTIONS, ALL THE DEVICES WERE REMOVED ON (B)(6) 2021. AN ANTIBIOTIC SPACER WAS PLACED AT THE SITE; THERE MAY BE A SHOULDER REVISION DONE IN THE FUTURE. REMOVED AR-9501-05P, AR-9502F-36RCPC, AR-9564-2433-LAT, AR-9503-3633-3C, AR-9560-24, AR-9561-30S.

  Patient problems: Unspecified Infection

  MAUDE report 11871983 ↗