Arthrex® AR-9503S-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00888867061316), received between Nov 8, 2016 and Mar 17, 2026 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (3 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2026Positioning Failure

  ON 25-FEB-2026, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-9503S-06 ARTHREX UNIVERS REVERS HUMERAL INSERT SMALL / 36 / +6 WOULD NOT SEAT WITHIN THE AR-9502F-36LCPC ARTHREX UNIVERS REVERS SUTURE CUP, 36 (+2 LEFT). THE INSERTER WAS REMOVED, AND ANOTHER AR-9503S-06 HUMERAL INSERT FROM THE SAME LOT WAS USED WITH THE ORIGINAL SUTURE CUP WITHOUT ISSUE. NO BREAKAGE OCCURRED. THERE WAS NO CASE DELAY OR ADDITIONAL ANESTHESIA TIME. THE EVENT WAS IDENTIFIED DURING A REVERSE TOTAL SHOULDER PROCEDURE ON (B)(6) 2026. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24620574 ↗
• InjuryAug 20, 2024Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth; Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth

  ADDITIONAL INFORMATION RECEIVED ON 5/14/2025: THE REVISION SURGERY WAS RESCHEDULED PER PATIENT REQUEST TO (B)(6) 2025. IT WAS LATER RESCHEDULED TO (B)(6) 2025 DUE TO SURGEON AVAILABILITY. AND THEN, RESCHEDULED AGAIN PER PATIENT REQUEST TO (B)(6) 2025. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Bacterial Infection; Loss of Range of Motion; Pain

  MAUDE report 20007229 ↗
• InjuryApr 18, 2023Unexpected Therapeutic Results; Patient Device Interaction Problem; Unexpected Therapeutic Results; Patient Device Interaction Problem

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A REVISION SHOULDER ARTHROPLASTY PROCEDURE TOOK PLACE ON (B)(6) 2023 DUE TO AN INFECTION. THE SURGEON REMOVED AN AR-9580-2420 UNIVERS REVERS MODULAR GLENOID SYSTEM AUGMENTED BASEPLATE, AN AR-9582-20 MODULAR POST FOR AUGMENTED MGS BASEPLATE, AN AR-9562-32NL UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, NON-LOCKING 4.5 X 32 MM, AN AR-9562-24NL UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, NON-LOCKING 4.5 X 24 MM, AN AR-9563-20 UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, LOCKING 5.5 X 20 MM, AN AR-9563-16 UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, LOCKING 5.5 X 16 MM, AN AR-9564-2436-LAT ARTHREX UNIVERS REVERS MODULAR GLENOID SYSTEM GLENOSPHERE, AN AR-9503S-06 ARTHREX UNIVERS REVERS HUMERAL INSERT, AN AR-9502F-36CPC ARTHREX UNIVERS REVERS SUTURE CUP, AND AN AR-9501-05P UNIVERS REVERS HUMERAL STEM. ADDITIONAL INFORMATION RECEIVED ON 3/23/2023: THE ORIGINAL PROCEDURE OCCURRED ON 3/22/2021. ABOUT TEN MONTHS LATER, THE PATIENT STARTED TO EXPERIENCE SYMPTOMS OF INFECTION. A CULTURE WAS TAKEN OFF THE INFECTED AREAS, BUT RESULTS ARE STILL PENDING. THE SAME SURGEON AT THE

  Patient problems: Unspecified Infection

  MAUDE report 16762827 ↗
• InjuryMay 31, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A PATIENT UNDER WENT A PRIMARY REVERSE PROCEDURE AND FELL 14 MONTHS LATER, POST OPERATIVE. IMMEDIATELY AFTER THE FALL, PATIENT EXPERIENCE SHOULDER PAIN RADIOGRAPHS SHOWED EVIDENCE OF A BROKEN AR-9563-32 PERIPHERAL LOCKING SCREW, A SHIFTER BASEPLATE AND GLENOSPHERE. A REVISION SURGERY TOOK PLACE ON (B)(6) 2022 FOR REMOVAL OF AR-9563-32 PERIPHERAL LOCKING SCREW, WHICH WAS ONLY PARTIALLY REMOVED, SURGEON MADE THE DECISION TO LEAVE A PORTION OF THE BROKEN SCREW, AS ATTEMPTING TO RETRIEVE IT MAY HAVE RESULTED IN ADDITIONAL BONE LOSS. AN AR-9563-28 PERIPHERAL LOCKING SCREW, AN AR-9561-25S CENTRAL SCREW, AN AR-9560-24-2 BASEPLATE, AN AR-9564-2436-LAT GLENO SPHERE, AND AN AR-9503S-06 HUMERAL INSERT WERE ALL EXPLANTED DURING REVISION REVERSE TSA PROCEDURE ON (B)(6) 2022. SURGEON COMPLETED CASE IMPLANTING NEW GLENOID IMPLANTS.

  Patient problems: Fall; Foreign Body In Patient; Pain

  MAUDE report 14547432 ↗
• InjuryMar 15, 2021Loose or Intermittent Connection

  IT WAS REPORTED THROUGH THE SURGICAL OUTCOME SYSTEM THAT A REVISION SURGERY IS REQUIRED DUE TO THE LOOSENING OF AN ARTHREX PROSTHETIC JOINT. THE PRIMARY SURGERY TOOK PLACE ON (B)(6) 2020. THE COMPLICATION WAS REPORTED ON (B)(6) 2020; INDICATING LOOSENING OF PROSTHETIC JOINT AND A REVISION REQUIRED. THE REVISION SURGERY TOOK PLACE ON (B)(6) 2021. THE FOLLOWING ARTHREX PRODUCT WAS EXPLANTED DURING THE REVISION SURGERY; AR-9560-24 (LOT: 5655); AR-9561-20P (LOT: 7038); AR-9562-36NL (LOT: 2018005757); AR-9562-40NL (LOT: 2018001457); AR-9563-20 (LOT: 2019003063); AR-9564-2436-LAT (LOT: 19.03388); AR-9502F-36RCPC (LOT: 19.00394); AR-9503S-06 (LOT: 170052510). THE FOLLOWING ARTHREX PRODUCT WAS IMPLANTED DURING THE REVISION SURGERY; AR-9502F-36RCPC (LOT: 20.01053); AR-9555-06 (LOT: 170143213); AR-9503S-06 (LOT: 20.01369).

  Patient problems: Failure of Implant

  MAUDE report 11485539 ↗
• InjuryAug 17, 2020Break

  IT WAS REPORTED THAT A PATIENT HAD UNDERGONE AN SHOULDER PROCEDURE (B)(6) 2019. DUE TO UPPER ARM/ BICEPS TENDON PAIN AND DISCOMFORT THE ORIGINAL SURGEON PERFORMED A REVISION RTSA PROCEDURE (B)(6) 2020 AT THE SAME FACILITY. DURING THE REVISION PROCEDURE WHILE ATTEMPTING TO REMOVE THE CUP SCREW FROM THE ORIGINAL PROCEDURE THE DRIVER TIP TWISTED AND THE SCREW STRIPPED. SALES REP STATES NOTHING OUT OF THE ORDINARY WAS NOTICED/ MENTIONED BY THE SURGEON DURING THE PROCEDURE. THE REVISION WAS COMPLETED WITHOUT ANY COMPLICATIONS. THE FOLLOWING DEVICES WERE EXPLANTED DURING THE REVISION AND EXCHANGED FOR LARGER SIZES: AR-9564-2436-LAT (LOT 18.01992), AR-9501-07P (LOT 18.02015), AR-9502F-36RCPC (LOT 170111405), AR-9503S-06 (LOT 19.00773), AR-9502RSC (LOT 18.01082), THE EXPLANTED DEVICES ARE NOT AVAILABLE TO RETURN FOR EVALUATION.

  Patient problems: Discomfort; Pain

  MAUDE report 10414444 ↗
• InjuryMay 6, 2020Fracture; Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED DURING A REVISION REVERSE SHOULDER TO A CLOSED REDUCTION PROCEDURE ON (B)(6) 2020, THE SURGEON WAS CHECKING IF THE PERIPHERAL SCREWS OF THE 24MM +2 MGS BASEPLATE WERE LOOSE. WHEN THE SURGEON TIGHTENED THE SCREWS, THE BLUE HANDLE OF THE AR-1999HH, RATCHETING HANDLE WAS CLICKING AND DID NOT HAVE A POSITIVE STOP. THE SURGEON DETERMINED THAT THE MGS BASEPLATE WAS LOOSE, SO THEY PROCEEDED TO EXPLANT THE SCREWS AND BASEPLATE WITHOUT ANY ISSUES. THE MGS BASEPLATE WAS IMPLANTED PRIOR TO THE REVISION SURGERY. THE IMPLANTS WERE CONVERTED TO TORNIER. AT THE TIME OF INITIAL REPORT TO ARTHREX NO FURTHER DETAILS WERE AVAILABLE. ADDITIONAL INFORMATION OBTAINED 04/13/2020 AND 04/15/2020: THE INITIAL REPORT PROVIDED WAS NOT A COMPLETE DESCRIPTION AND FURTHER, MORE DETAILED, INFORMATION HAS BEEN OBTAINED TO CLARIFY THE ENTIRE PATIENT RELATED EVENTS. THE FEMALE PATIENT UNDERWENT A PRIMARY REVERSE TOTAL SHOULDER PROCEDURE ON (B)(6) 2019. IT WAS REPORTED THAT THE PATIENT HAD SUFFERED A FALL (DATE UNKNOWN) WHICH RESULTED IN A PERIPROSTHETIC HUMERAL FRACTURE. THE PATIENT UNDERWENT A FIRST REVISION ON (B)(6) 2020 WHERE THE SURGEON EXPLANTED THE FOLLOWING DEVICES AND REPLACED THEM WITH ANOT

  Patient problems: Fall

  MAUDE report 10028340 ↗
• InjuryApr 18, 2019Device Slipped

  IT WAS REPORTED A SHOULDER PROTHESIS SURGERY HAD BEEN PERFORMED ON (B)(6) 2019. SINCE THE GLENOSPHERE, PART NUMBER: AR-9504S-04, LOT: 18.00085 HAS LOOSENED POST-OP, A REVISION SURGERY TOOK PLACE ON (B)(6) 2019. THE GLENOSPHERE WAS REUSED DURING REVISION SURGERY, ONLY THE HUMERAL INSERT WAS REPLACED BY AR-9503S-06, BATCH NUMBER 18.00858. UPDATE SWIT, 01-APR-2019: THE SURGEON DECIDED TO FIX THE GLENOSPHERE AGAIN AND NOT REPLACING IT.

  Patient problems: No Code Available

  MAUDE report 8526610 ↗
• InjuryApr 4, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD UNDERGONE A TOTAL REVERSE SHOULDER PROCEDURE ON (B)(6) 2018 DURING WHICH THE FOLLOWING ARTHREX DEVICES WERE IMPLANTED: AR-9502F-36RCPC (LOT 170027905); AR-9502F-36CPC (LOT 170018606); AR-9501-06P (LOT 170088903); AR-9503S-03 (170085610); AR-9504S-INF (LOT 160071710); AR-9120-01 (LOT 170115115); AR-9165-20 (LOT 170056412); AR-9145-24 (LOT 170101712). PATIENT ALSO UNDERWENT A REVISION PROCEDURE ON (B)(6) 2018 DURING WHICH THE AR-9503S-03 WAS EXPLANTED AND AN AR-9503S-06 (LOT 170150113)WAS IMPLANTED. THE REVISION SURGERY IS BEING REPORTED UNDER CASE (B)(4). PATIENT HAS RECENTLY BEEN ADMITTED TO THE HOSPITAL DUE TO A SHOULDER INFECTION. THE INFECTION IS BEING REPORTED UNDER THE FOLLOWING: (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 8483659 ↗
• InjuryDec 4, 2018Device Dislodged or Dislocated

  IT WAS REPORTED BY THE SALES REP THAT THERE WAS A REVISION OF A RIGHT TOTAL SHOULDER CASE ON (B)(6) 2018. THE ORIGINAL DATE OF SURGERY WAS ON (B)(6) 2015. THE REVISION WAS DUE TO LIMITED RANGE OF MOTION AND PAIN. SEVEN DEVICES WERE REMOVED FROM THE PATIENT; THERE WAS PROXIMAL METALOSIS IN THE SHOULDER JOINT AND THE GLENOSPHERE HAD DISASSOCIATED FROM THE BASEPLATE. THE FOLLOWING ARTHREX REPLACEMENT DEVICES WERE IMPLANTED: AR-9504L-04, UNIVERS REVERSE GLENOSPHERE, LOT: 170142415; AR-9502F-42CPC, UNIVERS REVERSE SUTURECUP, LOT: 170117105; AND AR-9503L-06, UNIVERS REVERSE HUMERAL INSERT, LOT: 170170513. ADDITIONAL INFORMATION OBTAINED 11/8/2018: SALES REP HAS CONFIRMED THAT HIS ORIGINAL REPORT STATING 7 DEVICES WERE EXPLANTED WAS INCORRECT. ONLY THE FOLLOWING THREE DEVICES WERE EXPLANTED: AR-9503S-06 HUMERAL INSERT (LOT: 2601221201), AR-9502-36CPC CUP (LOT: 2501407907) AND AR-9504S-04 GLENOSPHERE (LOT: 2501346003). ALL THREE DEVICES ARE BEING RETURNED TO ARTHREX FOR EVALUATION. ACCORDING TO THE MEDICAL RECORDS DURING THE REVISION SURGERY THE SURGEON DISCOVERED THE GLENOSPHERE TO BE COMPLETELY DISASSOCIATED FROM THE BASEPLATE. THE SURGEON ALSO NOTED A SIGNIFICANT AMOUNT OF WEAR ON THE I

  Patient problems: Loss of Range of Motion; Pain; Toxicity

  MAUDE report 8129855 ↗
• InjuryJun 22, 2017Break; Positioning Problem; Unintended Movement

  IT WAS REPORTED THAT PER THE SURGEON, THE THICKNESS OF THE TRIAL DOES NOT MATCH THE THICKNESS OF THE IMPLANT, AR-9503S-06 ((B)(4)). THE FIX WAS STABLE WITH THE TRIAL BUT NOT WITH THE INSERT. THEY COULD NOT USE THE IMPLANT; THEY USED A SPACER AND ANOTHER POLY TO COMPLETE THE REVERSE TOTAL SHOULDER. THE CUP, AR-9502F-36CPC ((B)(4)), COULD NOT SCREW INTO THE STEM (AR-9501-06CPC). ANOTHER CUP WAS USED WITH THE SAME STEM. THIS OCCURRED OUTSIDE THE PATIENT. A (B)(6) MALE. ADDITIONAL INFORMATION OBTAINED 6/2/17: PER SALES REP, WHEN THEY USED THE TRIAL POLY THE SHOULDER WAS APPROPRIATELY TENSIONED ACCORDING TO THE SURGEON. THEREFORE, THE DECISION WAS MADE TO OPEN THE SAME POLY THAT THEY HAD TRIALED. SURGEON INSERTED THE ACTUAL POLY, AR-9503S-06 ((B)(4)) INTO THE STEM AND REDUCED THE SHOULDER. UPON REDUCTION THE SURGEON SAID THERE WAS A SIGNIFICANT DIFFERENCE IN TENSION WITH THE REAL POLY VS THE TRIAL POLY. THE SHOULDER DISLOCATED WHILE RUNNING THE ARM THROUGH RANGE OF MOTION, WHICH DID NOT HAPPEN WITH THE TRIAL INSERT IN. THEY THEN DOUBLE CHECKED THE PACKAGING TO ENSURE THAT THE POLY THAT WAS OPENED WAS IN FACT THE SAME SIZE THAT HAD BEEN TRIALED. SINCE THE SHOULDER WAS SO LOOSE WITH THE P

  Patient problems: Joint Dislocation

  MAUDE report 6661137 ↗
• InjuryNov 8, 2016Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT HAD PREVIOUSLY DISLOCATED THEIR SHOULDER AND HAD A REPAIR PERFORMED USING AN AR-9503S-06, ARTHREX UNIVERS REVERSE HUMERAL INSERT. THE PATIENT DISLOCATED THE PREVIOUS REPAIR ON (B)(6) 2016. PATIENT WAS SEEN BY THE SURGEON SHORTLY AFTER THAT. AN OPEN POLY EXCHANGE TOOK PLACE ON (B)(6) 2016 FOR THE PATIENT'S RIGHT SHOULDER. THE HUMERAL INSERT S/36/+6 (LOT: 2501250702) WAS REMOVED AND EXCHANGED FOR A TITANIUM SPACER (LOT: 2501464807) AND SMALL 36 +3 ARTHREX UNIVERS REVERS HUMERAL INSERT (LOT: 160043709).

  Patient problems: Joint Dislocation

  MAUDE report 6085150 ↗