Arthrex® AR-9562-28NLRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867296695), received between Oct 30, 2020 and Nov 18, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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 ON (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 IMPLANTED

  Patient problems: Insufficient Information

  MAUDE report 23586424 ↗
• 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 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 PERIPH

  Patient problems: Failure of Implant

  MAUDE report 17054704 ↗
• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 3/1/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A SHOULDER ARTHROPLASTY REVISION SURGERY TOOK PLACE ON (B)(6) 2023 DUE TO AN INFECTION. THE SURGEON REMOVED AN AR-9560-28 ARTHREX UNIVERS REVERS MODULAR GLENOID SYSTEM MODULAR BASEPLATE, AN AR-9502F-42LCPC ARTHREX UNIVERS REVERS SUTURE CUP, AN AR-9564-2842 ARTHREX UNIVERS REVERS MODULAR GLENOID SYSTEM GLENOSPHERE, AN AR-9503L-03 ARTHREX UNIVERS REVERS HUMERAL INSERT, (2) AR-9563-20 UNIVERS REVERS MODULAR GLENOID SYSTEM PERIPHERAL LOCKING SCREW, AN AR-9562-28NL UNIVERS REVERS MODULAR GLENOID SYSTEM PERIPHERAL NON-LOCKING SCREW, AN AR-9562-40NL UNIVERS REVERS MODULAR GLENOID SYSTEM PERIPHERAL NON-LOCKING SCREW, AN AR-9561-25P UNIVERS REVERS MODULAR GLENOID SYSTEM CENTRAL POST MODULA, AND AN AR-9501-05P UNIVERS REVERS HUMERAL STEM.

  Patient problems: Post Operative Wound Infection

  MAUDE report 16582171 ↗
• 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 11730998 ↗
• 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. SEE ATTACHED IMMEDIATE POST-OP X-RAY OF THE REVISION. 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 11730947 ↗
• 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 10763801 ↗
• 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 (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 10763776 ↗