Arthrex® AR-9503M-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00888867061255), received between Oct 8, 2018 and Apr 16, 2026 — classified as 8 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryApr 16, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT AFTER AN INVERSE SHOULDER PROSTHESIS SURGERY ON (B)(6) 2026 THE PATIENT HAS DEVELOPED AN INFECTION. ON (B)(6) 2026 ALL IMPLANTS WERE REMOVED AND THE AFFECTED AREAS WERE CLEANSED AND TREATED. A NEW PROSTHESIS WILL BE IMPLANTED IN 6-8 WEEKS.

  Patient problems: Unspecified Infection

  MAUDE report 24895209 ↗
• InjuryFeb 16, 2026Break; Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT ON 03-MAR-2026: THE PATIENT UNDERWENT A REVERSE TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2024 FOR A PRE-EXISTING INJURY AND ARTHRITIC CONDITION. POSTOPERATIVELY, THE PATIENT REPORTED PAIN AND STIFFNESS WITH SHOULDER MOVEMENT, WHICH GRADUALLY PROGRESSED TO PAIN AT REST. FROM APPROXIMATELY (B)(6) 2025 THROUGH (B)(6) 2026, THE PAIN INCREASED IN SEVERITY AND BEGAN TO IMPACT ACTIVITIES OF DAILY LIVING. THE PATIENT COMPLETED THE PRESCRIBED POSTOPERATIVE PHYSICAL THERAPY. DUE TO WORSENING SYMPTOMS, THE PATIENT CONSULTED AN ORTHOPEDIC SURGEON, WHO ORDERED A LEFT SHOULDER X-RAY FOLLOWED BY A CT SCAN FOR FURTHER EVALUATION.

  Patient problems: Discomfort; Pain

  MAUDE report 24345410 ↗
• InjuryNov 18, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 10/28/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT TWO AR-9502-39ARCA UNIVERS REVERS CA HUMERAL HEAD ADAPTER 39 COMPONENTS COULD NOT BE SECURED DURING SURGERY. THE PROCEDURE WAS A REVISION REVERSE SHOULDER ARTHROPLASTY ON (B)(6) 2025. DURING THE OPERATION, THE ORIGINAL LINER WAS REMOVED FROM THE PATIENT. WHEN ATTEMPTING TO PLACE BOTH AR-9502-39ARCA UNIVERS REVERS CA HUMERAL HEAD ADAPTER 39 INTO THE 39 SUTURE CUP, NEITHER ADAPTER WOULD SNAP INTO PLACE. 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 NOVEMBER 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 IMPLANT

  Patient problems: Insufficient Information

  MAUDE report 23586425 ↗
• InjuryAug 6, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AFTER A PATIENT WAS TREATED IN 2013 WITH AN UNIVERS REVERS WITH A 36 SUTURE CUP AND A UNIVERSAL GLENOID (39 GLENOSPHERE). THE PATIENT HAD A GUT SURGERY RECENTLY AND STARTED FEELING UNWELL AND HAVING SHOULDER PAIN. THE PATIENT VISITED THE SURGEON WHO THEN DISCOVERED THAT THERE WAS AN INFECTION IN THE RIGHT SHOULDER AND SAW COMPONENT LOOSENING AND WEAR IN THE CT SCAN. AT FIRST THE SURGEON REMOVED THE GLENOSPHERE AND SUTURE CUP WHICH WERE ALREADY LOOSE ON THE (B)(6) 2025 AND TOOK SAMPLES TO DETERMINE THE SOURCE OF THE INFECTION. THE SURGEON THEN REPORTED ON THE (B)(6) THAT EVERYTHING HAD TO BE REMOVED OUT DUE TO THE PATHOGEN BEING A MORE SERIOUS. UPON REMOVAL, THE SURGEON SAW A SEVERE METALOSIS AND TISSUE CHANGES AROUND THE IMPLANT AND THE IMPLANT ITSELF WAS COMPLETELY WORN. IT WAS FURTHER REPORTED THAT THERE WAS NO REPORT OF A PATIENT ACCIDENT SUCH AS A FALL OR OTHER INJURY THAT MAY HAVE CAUSED THIS. UPDATE DW 21-JUL-2025 FURTHER CLARIFICATION WAS PROVIDED THAT THERE WERE 2 REVISIONS, THE FIRST ONE WAS PERFORMED ON THE (B)(6) AND A SECOND ONE ON (B)(6). THE SECOND REVISION WHICH WAS PERFORMED ON THE (B)(6) 2025 IS HANDLED IN (B)(4). THE FOLLOWING DEVICES WERE REM

  Patient problems: Metal Related Pathology

  MAUDE report 22730828 ↗
• InjuryFeb 18, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 11/13/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA EMAIL THAT ARTHREX DEVICES WERE EXPLANTED FROM A PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 11/25/2024: THE PATIENT UNDERWENT A TOTAL SHOULDER ARTHROPLASTY, ROTATOR CUFF REPAIR, CAPSULAR RELEASE PROCEDURE ON (B)(6) 2024. A 24MM GLENOID UNIVERS REVERS BASEPLATE, A 35MM CENTRAL UNIVERS REVERS SCREW, A 5.5 X 28MM PERIPHERAL LOCK UNIVERS REVERS SCREW, A 5.5 X 32MM PERIPHERAL LOCK UNIVERS REVERS SCREW, A 5.5 X 16MM PERIPHERAL LOCK UNIVERS REVERS SCREW, A 5.5 X 16MM PERIPHERAL LOCK UNIVERS REVERS SCREW, A 24 X 39MM 4 LAT TAPER UNIVERS REVERS GLENOSPHERE, A 39 2MM REVERS SHOULDER CUP, A 14 APEX UNIVERS REVERS STEM, A 39 3 REVERS SHOULDER LINER, AND A 39 6MM REVERS SHOULDER HUMERAL SPACER WERE IMPLANT. DUE TO AN INJURY THE PATIENT UNDERWENT REVISION SURGERY AND HAD THE 35MM CENTRAL UNIVERS REVERS SCREW, THE 5.5 X 28MM PERIPHERAL LOCK UNIVERS REVERS SCREW, AND THE 5.5 X 32MM PERIPHERAL LOCK UNIVERS REVERS SCREW REMOVED. THE REVISION SURGERY WAS COMPLETED WITHOUT IMPLANTING ANY ADDITIONAL ARTHREX PRODUCTS. BOTH SURGERIES WERE PERFORMED BY THE SAME SURGEONS AT THE SAME FACILITY. ADDITIONAL

  Patient problems: Failure of Implant

  MAUDE report 21400600 ↗
• MalfunctionApr 12, 2024Device Damaged Prior to Use; Device Damaged Prior to Use

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT (2) AR-9503M-03 HUMERAL INSERTS ARE DAMAGED. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME, WITH NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19100967 ↗
• MalfunctionSep 7, 2023Fitting Problem; Fitting Problem

  ON 8/8/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-9503M-03 UNIVERS REVERS HUMERAL INSERT, PART OF A LOANER SET WITH AN UNKNOWN PART NUMBER, HAD AN ISSUE DURING A REVERSE TOTAL SHOULDER PROCEDURE ON (B)(6) 2023. WHEN THE SURGEON WAS TRYING TO USE IT, THE IMPLANT WOULD NOT FIT AND SNAP INTO THE SUTURE CUP. NO PIECE BROKE OFF INSIDE THE PATIENT. ANOTHER SECOND AR-9503M-03 UNIVERS REVERS HUMERAL INSERT WITH AN UNKNOWN LOT NUMBER WAS USED IN THE PROCEDURE, AND IT WOULD SNAP RIGHT IN. THIS CAUSED A CASE DELAY OF OVER 15 MINUTES. IT COULD NOT BE CONFIRMED IF ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT. THE PROCEDURE WAS THEN COMPLETED SUCCESSFULLY WITH NO PATIENT HARM.

  Patient problems: Failure of Implant

  MAUDE report 17699600 ↗
• MalfunctionOct 17, 2022Break

  ON 9/28/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN A PATIENT UNDERWENT A REVERSE MODULAR SHOULDER PROCEDURE ON (B)(6) 2020. DURING THIS PROCEDURE AN AR-9501-13S APEX HUMERAL STEM, AN AR-9502F-39LCPC SUTURE CUP, AN AR-9503M-03 HUMERAL INSERT, AN AR-9560-28-4 MODULAR BASEPLATE, AN AR-9561-35S CENTRAL SCREW, AN AR-9563-36 PERIPHERAL LOCKING SCREW, AN AR-9563-40 PERIPHERAL LOCKING SCREW, AND AN AR-9564-2839-LAT GLENOSPHERE, WERE SUCCESSFULLY IMPLANTED. TWO YEARS LATER, ON (B)(6) 2022, PATIENT UNDERWENT A REVISION REVERSE TOTAL SHOULDER PROCEDURE BECAUSE THE CENTRAL AND PERIPHERAL SCREWS BROKE OFF THE BASEPLATE. ADDITIONAL INFORMATION RECEIVED ON 9/30/2022: DURING REVISION SURGERY ON (B)(6) 2022, AN AR-9560-28-4 MODULAR BASEPLATE, AN AR-9561-35S CENTRAL SCREW, AN AR-9563-36 PERIPHERAL LOCKING SCREW, AND AR-9563-40 PERIPHERAL LOCKING SCREW, AND AN AR-9564-2839-LAT GLENOSPHERE WERE REMOVED. PROCEDURE WAS COMPLETED BY IMPLANTING AN AR-9502-39ARCA UNIVERS REVERS CA HUMERAL HEAD ADAPTER FROM LOT NUMBER 18.00756 AND AN AR-9550-19RCA UNIVERS REVERS CA HUMERAL HEAD FROM LOT NUMBER 10248799 WERE IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 15615576 ↗
• InjuryApr 27, 2021Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THROUGH THE SURGICAL OUTCOME SYSTEM THAT A PATIENT EXPERIENCED AN INFECTION AFTER UNDERGOING A SHOULDER ARTHROPLASTY PROCEDURE CAUSING THE NEED FOR IMPLANT REMOVAL. THE PRIMARY PROCEDURE TOOK PLACE ON (B)(6) 2020. THE REVISION SURGERY WAS PERFORMED BY THE SAME SURGEON WHO PERFORMED THE PRIMARY AND TOOK PLACE AT THE SAME FACILITY AS THE ORIGINAL SURGERY. THE REVISION TOOK PLACE ON (B)(6) 2021. THE PART AND LOT NUMBERS OF EXPLANTED ARTHREX MATERIAL IS CURRENTLY UNKNOWN. THE PATIENT WAS REVISED WITH HEMI-ARTHROPLASTY, USING ARTHREX APEX. ADDITIONAL INFORMATION RECEIVED ON 4/9/2021: THE REP PROVIDED THE PART/LOT NUMBERS OF EXPLANTED ARTHREX PRODUCT THAT WAS REMOVED DURING THE REVISION SURGERY. SEE EXPLANTED MATERIAL LISTED BELOW; AR-9561-25P / LOT: 8013. AR-9560-28-4 / LOT: 6807. AR-9501-06S / LOT: 19.03511. AR-9502F-39LCPC / LOT: 19.02275. AR-9564-2839-LAT / LOT: 19.01015. AR-9564-2839 / LOT: 19.00603. AR-9562-28NL / LOT: 18.00143. AR-9503M-03 / LOT: 18.01724. AR-9505-06 / LOT: 19.03720. AR-9563-28 / LOT: 2019003486 (X 2). AR-9562-28NL / LOT: 2019001689.

  Patient problems: Unspecified Infection

  MAUDE report 11730939 ↗
• MalfunctionApr 7, 2021Material Protrusion/Extrusion; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A REVISION WAS NECESSARY AFTER A DISTAL PROTRUSION OF THE LONG HUMERAL SHAFT. THE PATIENT WILL BE REHABILITATED AT A LATER DATE AFTER A HUMERAL BONE GRAFTING PROCEDURE. THE BASE PLATE INCLUDING SCREWS HAVE REMAINED IN THE PATIENT. NO FURTHER INFORMATION WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11630240 ↗
• InjuryFeb 25, 2020Improper or Incorrect Procedure or Method

  IT WAS REPORTED BY THE PATIENT'S LEGAL REPRESENTATIVE THAT ON OR ABOUT (B)(6) 2017 THE PATIENT UNDERWENT A SHOULDER ARTHROPLASTY SURGERY. IT WAS REPORTED THAT THE OPERATION REQUIRED IMPLANTATION OF A SPECIFIC MILLIMETER-SIZED POLYETHYLENE LINER AND THE WRONG SIZED LINER WAS PROVIDED TO THE SURGEON. IT WAS FURTHER REPORTED THAT THE HARDWARE IMPLANTED DID NOT MATCH THE TRIAL COMPONENTS THE SURGEON HAD SELECTED FOR THE PATIENT AND IMPROPER PROSTHETIC COMPONENTS WERE IMPLANTED CAUSING THE NEED FOR SUBSEQUENT SURGICAL TREATMENT. THE FOLLOWING DEVICES WERE IMPLANTED DURING THE INITIAL (B)(6) 2017 PROCEDURE: AR-9503S-03, UNIVERS REVERSHUMERAL INSERT SMALL/36/+3, LOT 170052310, AR-9502F-36CPC, UNIVERS REVER SUTURE CUP, 39 (NEUTRAL) (LOT 160117904 OR LOT 170039706 - SPECIFIC LOT UNKNOWN), AR-9501-07CPC, UNIVERS REVERS STEM, SIZE 7, LOT 170035214, AR-9504M-04, UNIVERS REVERS GLENOSPHERE 39 +4 LAT, LOT 160123713, AR-9165-20NL, CENTRAL SCREW, NON-LOCKING, UNI REV, 6.5 X 20MM, LOT 10070240, AR-9145-30, UNI GLENOID-PERIPHERAL LOCKING SCREW, LOT 17009612, AR-9145-24, UNI GLENOID-PERIPHERAL LOCKING SCREW, LOT 160115411, AR-9120-02, UNIVERSAL GLENOID BASEPLATE MEDIUM, LOT 2501470208. ADDITIONAL INF

  Patient problems: No Code Available

  MAUDE report 9751186 ↗
• InjuryOct 8, 2018Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT REQUIRED A REVISION OF A REVERSE TOTAL SHOULDER DUE TO DISLOCATING. THIS WAS FOUND DURING A POST-OP VISIT. THE AR-9503M-03 WAS REMOVED AND REPLACED WITH AR-9503M-06C. ADDITIONAL INFORMATION OBTAINED AT TIME OF INITIAL REPORT: ORIGINAL SURGERY WAS A SUBSCAP TENDON REPAIR ON (B)(6) 2018. DUE TO TENDON BE DAMAGED AGAIN A REVERSE TOTAL SHOULDER REVISION WAS PERFORMED ON (B)(6) 2018. EXPLANTED DEVICE WAS DISCARDED BY FACILITY. ADDITIONAL INFORMATION IS BEING REQUESTED. ADDITIONAL INFORMATION OBTAINED 9/18/2018: ON (B)(6) 2018 THE PATIENT RECEIVED A REVERSE TOTAL SHOULDER PROCEDURE. AT THAT TIME AFTER EVERYTHING WAS IMPLANTED THE SURGEON PERFORMED A SUBSCAP REPAIR WITH #5 ETHIBOND. PATIENT HAD A FOLLOW UP VISIT ON (B)(6) 2018 AND PATIENT STATED THAT HE HAD DISLOCATED AGAIN. X-RAYS WERE TAKEN AND EVERYTHING APPEARED NORMAL. X-RAYS HAVE BEEN PROVIDED TO ARTHREX FROM THE POST OP VISIT WHERE PATIENT STATED HE HAD DISLOCATED. PATIENT STATED HE HAD NO FALL OR TRAUMA BEFORE THE FOLLOW UP VISIT THAT LEAD TO THE DISLOCATION. UPON OPENING THE PATIENT DURING THE (B)(6) 2018 REVISION IT WAS DETERMINED THAT THE SUBSCAP REPAIR THAT WAS DONE ON THE ORIGINAL PROCEDURE HA

  Patient problems: Joint Dislocation

  MAUDE report 7943773 ↗