Arthrex® AR-9502F-39RCPCRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867234246), received between Oct 30, 2020 and Feb 18, 2025 — classified as 3 injuries.

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

• 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 REMOV.

  Patient problems: Failure of Implant

  MAUDE report 21399638 ↗
• 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 11798532 ↗
• 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: Nerve Damage; Numbness

  MAUDE report 10763603 ↗