Arthrex® AR-9501-07PRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867250390), received between Aug 17, 2020 and Nov 19, 2024 — classified as 4 injuries, 1 malfunction.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 19, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9564-2442-LAT GLENOSPHERE AND GLENOSPHERE SET SCREW DISENGAGED FROM THE BASEPLATE. THE PATIENT UNDERWENT SURGERY ON (B)(6) 2023 FOR A REVERSE SHOULDER ARTHROPLASTY. POSTOPERATIVELY THE PATIENT EXPERIENCED PAIN AND A CT SCAN REVEALED GLENOSPHERE AND GLENOSPHERE SET SCREW DISENGAGED FROM THE BASEPLATE. ON (B)(6) 2023 THE PATIENT UNDERWENT A REVISION SURGERY IN WHICH A NEW GLENOSPHERE ALONG WITH HUMERAL COMPONENTS WERE IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 11/4/2024: DURING THE REVISION SURGERY, THE AR-9502F-39LCPC SUTURECUP, THE AR-9503-3942-3 HUMERAL INSERT, THE AR-9501-07P HUMERAL STEM, THE AR-9582-20 MODULAR POST, THE AR-9563-28 PERIPHERAL LOCKING SCREW, THE AR-9563-16 PERIPHERAL LOCKING SCREW, THE AR-9563-20 PERIPHERAL LOCKING SCREW, THE AR-9562-40NL PERIPHERAL LOCKING SCREW, THE AR-9580-2010-2S BASEPLATE, AND AR-9564-2442-LAT GLENOSPHERE WAS REMOVED. BOTH PROCEDURES WERE PERFORMED BY THE SAME SURGEON AND AT THE SAME FACILITY.

  Patient problems: Pain

  MAUDE report 20726273 ↗
• InjuryJul 25, 2022Adverse Event Without Identified Device or Use Problem

  ON 07/8/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAN AN AR-9501-07P UNIVERS REVERS HUMERAL STEM WAS REMOVED DURING A REVISION REVERSE TOTAL SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2022 DUE TO AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 15093533 ↗
• MalfunctionJun 7, 2021Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT HAD A REVERSE SHOULDER DONE ON (B)(6) 2019. SHE WAS HAVING INFLAMMATION PROBLEMS AT THE SITE; THERE WAS ANOTHER CASE DONE ON (B)(6) 2021 TO REMOVE THE DEVICES. THEY CHECKED FOR INFECTION; TESTS WERE NEGATIVE. THE SURGEON DETERMINED THAT THE STEM AND CUP WERE LOOSE; THEY WERE REMOVED FROM THE PATIENT. A SIZE 8 STEM AND CUP WERE INSERTED INTO THE PATIENT FOR A TOTAL SHOULDER REPAIR.

  Patient problems: Inflammation

  MAUDE report 11947503 ↗
• InjuryMar 15, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE SURGICAL OUTCOME SYSTEM THAT A PULMONARY EMBOLISM RESULTING IN INPATIENT HOSPITALIZATION OCCURRED DURING A SHOULDER ARTHROPLASTY PROCEDURE IN WHICH ARTHREX PRODUCT WAS BEING USED. THE PATIENT WAS TREATED WITH CONCOMITANT MEDICATION. THE FACILITY REPORTED THAT THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL AND IS RECOVERING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11484416 ↗
• InjuryAug 17, 2020Patient-Device Incompatibility

  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 10414362 ↗