Arthrex® AR-9501-07SRecalls & reported problems
Arthrex, Inc. · UNIVERS REVERS APEX STEM, SIZE 7 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867250482), received between Dec 20, 2019 and Dec 20, 2019 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Anemia1
- Atrial Fibrillation1
- Hematoma1
- Tissue Breakdown1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 20, 2019Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED VIA THE SURGICAL OUTCOME SYSTEM THAT A PATIENT WAS HAVING COMPLICATIONS POSSIBLY RELATED TO A PRIOR IMPLANTED ARTHREX PRODUCT. COMPLICATIONS MENTIONED WERE HEMATOMA. ADDITIONAL INFORMATION OBTAINED 12/3/2019: THE SURGEON'S REPRESENTATIVE HAS CONFIRMED THAT A PATIENT HAD AN INITIAL PRIOR ROTATOR CUFF REPAIR AND REQUIRED A SECOND LEFT REVERSE SHOULDER ARTHROPLASTY ON (B)(6) 2019. THE OPERATIVE REPORT FROM 11/13/2019 NOTED THAT THREE METAL CORKSCREW ANCHORS HAD BEEN EXPLANTED PRIOR TO PROCEEDING WITH THE PROCEDURE. DURING THE PROCEDURE THE FOLLOWING ARTHREX PRODUCTS WERE IMPLANTED: AR-9564-2442-LAT (MODULAR GLENOSPHERE), AR-9501-07S (HUMERAL STEM) AND AR-9502F-42LCPC (SUTURE CUP). ON (B)(6) 2019 THE PATIENT WAS ADMITTED TO THE HOSPITAL URGENTLY AFTER HIS LARGE HEMATOMA BEGAN TO HAVE WOUND BREAKDOWN AND HE HAD ANEMIA WITH SYMPTOMATIC ATRIAL FIBRILLATION WITH RVR. SURGEON ADMITTED THE PATIENT FOR SURGICAL EXPLORATION WITH EVACUATION OF HEMATOMA, DEBRIDEMENT, EXPLORATION OF TENDON TRANSFER SITE AND ADMINISTRATION OF LOCAL ANTIBIOTICS. OPERATIVE REPORT NOTED THERE WAS NO EVIDENCE OF INFECTION AND THE SUBSCAPULARIS REPAIR AND THE TENDON TRANSFER REPAIR WERE INTACT. THE PROS
Patient problems: Anemia; Atrial Fibrillation; Hematoma; Tissue Breakdown
MAUDE report 9506047 ↗
Other shoulder prosthesis, reverse configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page