Arthrex® AR-9564-2439-LATRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888867295711), received between Oct 28, 2020 and Jun 3, 2026 — classified as 10 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (6 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 10 most recent of 10 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 25375329 ↗
• 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 24903208 ↗
• InjuryMar 4, 2026Patient Device Interaction Problem

  ON 28-JAN-2026, THE PATIENT REPORTED VIA EMAIL THAT, FOLLOWING A REVERSE TOTAL SHOULDER SURGERY, THEY EXPERIENCED INCREASING POSTOPERATIVE PAIN. X-RAYS REPORTEDLY SHOWED A BROKEN SCREW, AND A CT SCAN DEMONSTRATED A LOOSE IMPLANT. THE PATIENT IS NOW SCHEDULED FOR A CORRECTIVE SURGICAL PROCEDURE. NO ADDITIONAL DETAILS WERE PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED VIA PHONE FROM THE PATIENT'S RELATIVE ON 09-FEB-2026: THE PATIENT IS SCHEDULED TO UNDERGO A REVISION LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2026. THE ORIGINAL PROCEDURE WAS PERFORMED ON (B)(6) 2024 BY A DIFFERENT SURGEON AT A DIFFERENT FACILITY. OVER TIME, THE PATIENT DEVELOPED SIGNIFICANT LEFT SHOULDER PAIN. THE PATIENT¿S SPOUSE REPORTED PROGRESSIVE DISCOMFORT IN THE PATIENT¿S LEFT ARM. DIAGNOSTIC IMAGING WAS PERFORMED, INCLUDING AN X-RAY ON (B)(6) 2025, WHICH IDENTIFIED A FRACTURED SCREW, FOLLOWED BY A CT SCAN ON (B)(6) 2025 THAT DEMONSTRATED LOOSENING OF THE IMPLANT. ADDITIONAL INFORMATION WAS RECEIVED VIA PHONE FROM THE PATIENT'S RELATIVE ON 10-FEB-2026: THE PATIENT'S SPOUSE REPORTED THAT THE REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, ALL COMPONENTS OF THE LEFT SHOULDER WERE R

  Patient problems: Discomfort; Pain

  MAUDE report 24512262 ↗
• InjuryNov 18, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 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 (B)(6) 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 IMPLANTE

  Patient problems: Insufficient Information

  MAUDE report 23586414 ↗
• InjuryJul 16, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2025, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY HAD EXPERIENCED A DEEP INFECTION. ON (B)(6) 2025, THE PATIENT PRESENTED WITH INCREASED SWELLING AND ACHING IN THE OPERATIVE SHOULDER, WITH SYMPTOMS REPORTED TO HAVE BEGUN ABOUT THREE TO FOUR WEEKS PRIOR TO THE CLINIC VISIT ON (B)(6) 2025. THE PATIENT WAS REFERRED FOR SYNOVASURE TESTING ON (B)(6) 2025, AND A VISIT ON (B)(6) 2025 CONFIRMED THE INFECTION. A REVISION WAS SUBSEQUENTLY PERFORMED ON (B)(6) 2025. THE EVENT WAS INDICATED AS UNRELATED TO THE UNIVERS REVERS APEX IMPLANTED ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 6/20/2025: DURING THE REVISION SURGERY ON (B)(6) 2025, AN AR-9501-11S UNIVERS REVERS APEX HUMERAL STEM, AN AR-9502F-36CPC ARTHREX UNIVERS REVERS SUTURE CUP, AN AR-9503-3639-3 UNIVERS REVERS MODULAR GLENOID SYSTEM COMBO HUMERAL INSERT, TWO AR-9563-16 UNIVERS REVERS MODULAR GLENOID SYSTEM PERIPHERAL LOCKING SCREW, AN AR-9563-24 UNIVERS REVERS MODULAR GLENOID SYSTEM PERIPHERAL LOCKING SCREW, AN AR-9563-32 UNIVERS REVERS MODULAR GLENOID SYSTEM PERIPHERAL LOCKING SCREW, AN AR-9564-2439-LAT ARTHREX UNIVERS REVERS MODULAR GLENOID SYSTEM GLENOSP

  Patient problems: Unspecified Infection

  MAUDE report 22521365 ↗
• InjuryJan 15, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 12/18/2024, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY, FIVE MONTHS POSTOPERATIVE, PRESENTED WITH FULLNESS IN THE ANTERIOR OF THE DELTOPECTORAL INCISION, WHICH HAS TO BE FLUCTUANCE. THE INCISION WAS DRAINED, AND A CULTURE WAS SENT TO THE LAB, WHICH INDICATED AN INFECTION. THE PHYSICIAN DECIDED TO PLACE A PICC LINE FOR IV ANTIBIOTICS. THE PATIENT ALSO UNDERWENT AN EXPLANT PROCEDURE AND HAD AN ANTIBIOTIC CEMENT SPACER IMPLANTED ON (B)(6) 2024. THE PATIENT WAS ORIGINALLY IMPLANTED ON (B)(6) 2024. THIS EVENT WAS INDICATED AS UNRELATED TO THE UNIVERS REVERS APEX IMPLANT SYSTEM. ADDITIONAL INFORMATION RECEIVED ON 1/3/2024: DURING THE REVISION SURGERY, AN AR-9503-3639-3 HUMERAL INSERT, AN AR-9563-16 PERIPHERAL SCREW, AN AR-9563-24 PERIPHERAL SCREW, AN AR-9563-32 PERIPHERAL SCREW, AN AR-9563-44 PERIPHERAL SCREW, AN AR-9564-2439-LAT GLENOSPHERE, AN AR-9580-2420-2S BASEPLATE, AND AR-9582-25 MODULAR POST WERE EXPLANTED. THE REVISION SURGERY WAS COMPLETED USING PRODUCTS FROM ANOTHER MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 21160468 ↗
• InjurySep 19, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT ON THE (B)(6) 2023 AN INVERSE STEP WITH MOD. GLENOID WAS IMPLANTED INTO THE PATIENT. REHAB AND POST-OP PROGRAM WAS DONE PROPERLY AND WITHOUT COMPLICATIONS. ON THE (B)(6) 2023 THE PATIENT WAS A PASSENGER IN A CAR AND WHILE TRYING TO POSITION BETTER IN THE SEAT WITH THE HELP OF THE HANDLE ABOVE THE WINDOW THE SCREW CAME LOOSE FROM THE GLENOSPHERE. THIS RESULTED IN A REVISION ON (B)(6) 2023 WHERE THE IMPLANT WAS REMOVED COMPLETELY OUT OF THE PATIENT AND AGLENOSPHERE IN A DIFFERENT SIZE (AR-9564-2439 BATCH: 21.01813) WAS IMPLANTED. THE REVISION SURGERY WAS FINISHED SUCCESSFULLY. ***UPDATE, KHE, 18-SEP-2023 AN UNKNOWN SCREW WAS RECEIVED WITH THE AR-9564-2439-LAT.

  Patient problems: Failure of Implant

  MAUDE report 17774045 ↗
• InjuryJun 2, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 5/10/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9580-2420-2 BASEPLATE WAS LOOSENED POST-OPERATIVE. IN (B)(6) OF 2023, THE PATIENT REPORTED AN ONGOING PAINFUL SHOULDER, AND RADIOGRAPHS REVEALED THE LOOSENED BASEPLATE WITH A POST-MIGRATING SUPERIOR POSTERIOR OF THE GLENOID. A REVISION SURGERY TOOK PLACE ON (B)(6)2023 TO REMOVE THE DEVICES IMPLANTED DURING THE ORIGINAL PROCEDURE ON (B)(6)2021. DURING THE REVISION OF SHOULDER ARTHROPLASTY, AN AR-9580-2420-2 BASEPLATE, AN AR-9582-25 MODULAR POST, AN AR-9563-16, AN AR-9563-24 PERIPHERAL SCREW, AN AR-9562-28NL PERIPHERAL SCREW, AN AR-9562-24NL PERIPHERAL SCREW, AND AN AR-9564-2439-LAT GLENOSPHERE WERE SUCCESSFULLY REMOVED. BOTH PROCEDURES WERE PERFORMED AT THE SAME FACILITY AND BY THE SAME SURGEON. ADDITIONAL INFORMATION RECEIVED ON 5/11/2023: THE REVISION SURGERY WAS COMPLETED BY IMPLANTING AN AR-9503M-03 HUMERAL INSERT M/39 +3 TO FIT IN 39 CUP , AN AR-9505-09 UNIVERS REVERS SPACER 39+9MM, AN AR-9563-32 5.5X32MM PERIPHERAL SCREW, LOCKING, AN AR-9564-2839 39/28 GLENOSPHERE, AN AR-9560-28 28MM BASEPLATE, MODULAR, AN AR-9562-24NL 4.5X24MM PERIPHERAL SCREW, NON-LOCKING, AND AR-9563-20 5.5X20MM PERIPHERAL SCREW, L

  Patient problems: Failure of Implant

  MAUDE report 17054724 ↗
• 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. (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 REP C

  Patient problems: Fall

  MAUDE report 11798396 ↗
• InjuryOct 28, 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 (B)(6) 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.

  Patient problems: Failure of Implant

  MAUDE report 10747406 ↗