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

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888867061279), received between Mar 21, 2019 and Jun 3, 2026 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2026Patient Device Interaction Problem

  ON 19-MAY-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN ARTHREX REVERSE TOTAL SHOULDER ARTHROPLASTY (RTSA) SYSTEM WAS EXPLANTED DURING A REVISION PROCEDURE. UPON EXAMINATION OF THE REMOVED HUMERAL COMPONENTS, THE AR-9502F-39CPC ARTHREX UNIVERS REVERSE SUTURE CUP, 39 (NEUTRAL), WAS OBSERVED TO BE LOOSE FROM THE AR-9501-06P ARTHREX UNIVERS REVERSE HUMERAL STEM, SIZE 6, WHILE THE HUMERAL STEM REMAINED FIRMLY SEATED IN THE HUMERAL CANAL WITHOUT EVIDENCE OF LOOSENING. ADDITIONALLY, THE FRONT SURFACE OF THE BASEPLATE AND THE BACKSIDE OF THE AR-9564-2439-LAT GLENOSPHERE 39 +4 LAT/24 WERE NOTED TO BE COVERED WITH A WHITE/BEIGE SUBSTANCE. THERE WAS A REPORTED CONCERN FOR A POSSIBLE ASSOCIATED INFECTION. ALL ARTHREX IMPLANTS, INCLUDING THE GLENOSPHERE AND THE POLYETHYLENE COMPONENT, AR-9503M-06 HUMERAL INSERT, M/39/+6, WERE REMOVED. THE SURGICAL SITE WAS IRRIGATED, AND A TEMPORARY SPACER WAS PLACED. ADDITIONAL INFORMATION WAS RECEIVED ON 28-MAY-2026: THE REVISION PROCEDURE WAS PERFORMED DUE TO SUSPECTED IMPLANT LOOSENING AND INFECTION. THE ONSET OF SYMPTOMS FOLLOWING THE INITIAL SURGERY IS UNKNOWN; HOWEVER, THE PATIENT REPORTED PAIN PRIOR TO REVISION. PRE-OPERATIVE ASSESSMENT INDIC

  Patient problems: Unspecified Infection

  MAUDE report 25375328 ↗
• MalfunctionMay 1, 2024Defective Device; Defective Device

  ON 09/07/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT (2) AR-9503M-06 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 19221544 ↗
• InjuryJul 6, 2023Break; Break

  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 06/15/2023 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 17273044 ↗
• InjuryFeb 7, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2022, IT WAS REPORTED THROUGH THE SURGICAL OUTCOME SYSTEM THAT A REVISION SURGERY IS REQUIRED DUE TO A COMPLICATION AND A LOOSENING OF AN ARTHROPLASTY IMPLANT. THE DATE OF THE PRIMARY PROCEDURE WAS ON (B)(6) 2017 FOR A LEFT REVERSE TOTAL SHOULDER REPLACEMENT WERE AN UNIVERS REVERS, GLENOSPHERE SIZE (39MM), GLENOSPHERE OFFSET (4MM LATERAL), STEM FIXATION (PRESSFIT), STEM SIZE (6), AND SUTURECUP (2MM POSTERIOR) WAS IMPLANTED. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED 1/20/2022: THE COMPLICATION WAS REPORTED ON (B)(6) 2018. THE DATE OF THE REVISION PROCEDURE WAS (B)(6) 2018 FOR A RSA WITH CANCELLOUS ALLOGRAFT AND AN AR-9120-01 AND AN AR-9503M-06 WAS EXPLANTED. DEVICE(S) WERE DISCARDED.

  Patient problems: Insufficient Information

  MAUDE report 13471406 ↗
• MalfunctionJun 28, 2021Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RTSA PROCEDURE ON (B)(6) 2020. A REVISION WAS THEN PERFORMED DUE TO A LOOSENED GLENOSPHERE ON (B)(6) 2021 WHERE THE FOLLOWING DEVICES WERE EXPLANTED: AR-9564-2839 LOT: 19.00602; AR-9503M-06 LOT: 19.04678.

  Patient problems: Joint Laxity

  MAUDE report 12075690 ↗
• InjuryMay 10, 2021Break; Fracture; Malposition of Device

  IT WAS REPORTED THAT THE SURGEON IMPLANTED A UNIVERS REVERS APEX AND MODULAR GLENOID SYSTEM (MGS) CONSTRUCT DURING A PRIMARY RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY CASE. THE PATIENT INCREASED ACTIVITY PER THE STANDARD PROTOCOL. AT 19 MONTHS POST-OP, THE PATIENT FELL AND HAD A PERIPROSTHETIC FRACTURE. AT THE TIME OF REVISION FOR THE PERIPROSTHETIC FRACTURE, THE PATIENT HAD A STABLE MODULAR GLENOID SYSTEM IMPLANT CONSTRUCT. THE REVERS APEX HUMERAL IMPLANTS WERE REMOVED. THE WRIGHT MEDICAL REVIVE REVISION HUMERAL STEM WAS IMPLANTED DUE TO THE PERIPROSTHETIC FRACTURE. AT 26 MONTHS POST-OP FROM THE INITIAL INDEX REVERSE TOTAL SHOULDER PROCEDURE, THE PATIENT PRESENTED WITH NO FUNCTION. X-RAYS SHOWED A FAILED MODULAR GLENOID SYSTEM IMPLANT CONSTRUCT. THE INFERIOR SCREW WAS BROKEN AND THE IMPLANTS HAD SHIFTED. ON (B)(6) 2021, A SECOND REVISION WAS PERFORMED TO REMOVE THE MODULAR GLENOID SYSTEM IMPLANTS. THE GLENOID IMPLANTS WERE REMOVED IN ONE PIECE WITH NO BONE ON GROWTH. A WRIGHT MEDICAL REVERSE GLENOID CONSTRUCT WAS IMPLANTED IN PLACE. NO INFECTION. ADDITIONAL INFORMATION RECEIVED ON 4/27/2021: THE REP REPORTED THE PRIMARY REVERS TOTAL SHOULDER SURGERY WAS DONE ON (B)(6) 2019. THE RE

  Patient problems: Fall

  MAUDE report 11798536 ↗
• InjuryDec 7, 2020Loose or Intermittent Connection

  IT WAS REPORTED THROUGH THE SURGICAL OUTCOME SYSTEM THAT A ISSUE POSSIBLY RELATED TO AN ARTHREX PRODUCT TOOK PLACE. UPON FURTHER INVESTIGATION THE FOLLOWING WAS DISCOVERED: A PATIENT HAD UNDERGONE A REVERSE TOTAL SHOULDER ARTHROPLASTY 3/20/2019. IT WAS DIAGNOSED VIA X-RAY AND CT SCAN (B)(6) 2020 THAT THE PATIENT WAS EXPERIENCING LOOSENING OF THE IMPLANT GLENOID SIDE. A REVISION OF GLENOID AND HUMERAL COMPONENTS WITH ALLOGRAFT SURGERY WAS PERFORMED (B)(6) 2020 DURING WHICH TIME THE FOLLOWING ORIGINAL ARTHREX IMPLANTS WERE EXPLANTED: ARTHREX UNIVERS REVERS MGS PERIPHERAL SCREW NL 4.5X24 MM; LOT #170182004; CATALOG # AR-9562-24NL. ARTHREX UNIVERS REVERS MGS PERIPHERAL SCREW 4.5X32 MM; LOT #2018001455; CATALOG # AR-9562-32NL; QTY 2. ARTHREX CENTRAL SCREW MODULAR 30 MM; LOT #5652; CATALOG # AR-9561-30S. ARTHREX GLENOSPHERE 39 +4 LAT/24; LOT #18.00656; CATALOG # AR-9564-2439-LAT. ARTHREX CUP UNIVERS REVS SUTURE 39MM NTRL +2 LEFT; LOT #170074105; CATALOG # AR-9502F-39LCPC. ARTHREX BASEPLATE 24 M MODULAR; LOT #5362; CATALOG # AR-9560-24. AFTER REMOVAL OF THE ABOVE DEVICES THE SURGEON PERFORMED A CONVERSION TO HEMIARTHROPLASTY WITH GLENOID BONE GRAFT. ADDITIONAL INFORMATION 11/16/2020: WHEN

  Patient problems: Failure of Implant

  MAUDE report 10958007 ↗
• InjuryOct 30, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE SURGICAL OUTCOME SYSTEM THAT A PATIENT MAY HAVE HAD AN ISSUE AS A RESULT OF SURGERY INVOLVING ARTHREX IMPLANTS. UPON FURTHER INVESTIGATION IT WAS DISCOVERED THAT A PATIENT HAD A (B)(6) 2019 REVERSE SHOULDER REPLACEMENT PROCEDURE. AFTER THE NERVE BLOCK HAD WORN OFF, APPROXIMATELY 24 HOURS POST SURGERY THE PATIENT WAS EXPERIENCING NUMBNESS IN THE SURGICAL ARM'S PALM, HALF OF RING FINGER AND THE PINKIE FINGER. THE PATIENT WAS DIAGNOSED WITH ULNAR NERVE PALSY AND TOLD IT MAY TAKE A YEAR TO RESOLVE. PATIENT CONSULTED WITH A NEUROLOGIST, WHO SAID NOTHING COULD BE DONE. THE ULNAR NERVE WAS DAMAGED. NO SECOND SURGERY HAS BEEN PERFORMED. THE FOLLOWING ARE THE ARTHREX PRODUCTS THAT WERE IMPLANTED ON (B)(6) 2019: AR-9560 28-4 / LOT: 6094; AR-9561-25P / LOT: 5685; AR-9502F-39RCPC / LOT: 19.00275; AR-9501-105 / LOT: 18.0037; AR-9564-2839-LAT / LOT: 18.02027; AR-9562-28NL / LOT: 2018005880; AR-9503M-06 / 19.00667; AR-9563-28 / LOT: 2019001687; AR-9563-24 / LOT: 19.02242; AR-9562-28NL / LOT: 2018005880.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Numbness

  MAUDE report 10763774 ↗
• InjuryMar 21, 2019Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TSA PROCEDURE ON (B)(6) 2018. 9 MONTHS POST-OP, ON (B)(6) 2019, THE PATIENT WAS SEEN BY THEIR SURGEON FOR A FOLLOW-UP VISIT WHERE AN X-RAY WAS TAKEN TO DETERMINE PROGRESS. THE X-RAY SHOWED THAT THE BASEPLATE AND GLENOSPHERE WERE DISLOCATED. THE PATIENT STATED THAT NO TRAUMA HAD OCCURRED. A COPY OF THE X-RAY IS UNABLE TO BE OBTAINED. A REVISION SURGERY TOOK PLACE ON (B)(6) 2019 AND THE FOLLOWING DEVICES WERE ALL EXPLANTED: AR-9145-30 / LOT: 170156313, AR-9145-36 / LOT: 170139313, AR-9504M / LOT: 140119609, AR-9503M-06 / LOT: 160010109, AR-9120-01 / LOT: 170145515, AND AR-9165-20 / LOT: 150008108. THE SURGEON SWITCHED TO AN RTSA AND IMPLANTED THE FOLLOWING: AR-9502-39ARCA / LOT: 261519 AND AR-9550-19RCA / LOT: 10031668. ADDITIONAL INFORMATION PROVIDED 3/29/2019: THE AR-9145-30 SCREW BROKE UPON REMOVAL OF HARDWARE. TIP WAS RETRIEVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8440395 ↗