Arthrex® AR-9501-11PRecalls & reported problems
Arthrex, Inc. · UNIVERS REVERS HUMERAL STEM, SIZE 11 · Class 2 · Implant
Data updated Oct 16, 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 00888867250437), received between Apr 4, 2025 and Apr 4, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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.
Reports received per month
Most reported problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Bone Fracture(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 4, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
ON (B)(6) 2025, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY SUFFERED LOOSENING OF HUMERAL SIDE IMPLANTS. THE PATIENT SUFFERED AN INJURY AFTER LIFTING A FIVE-POUND BOX. THE X-RAYS INDICATED A SMALL NON-DISPLACED FRACTURE AND LOOSE HUMERAL COMPONENTS. THE PATIENT UNDERWENT A REVISION RSA AND OFIF PROCEDURE ON (B)(6) 2022. THIS EVENT WAS INDICATED AS UNRELATED TO THE UNIVERSE REVERSE SYSTEM IMPLANTED ON (B)(6) 2020. NO FURTHER INFORMATION WAS REPORTED. ADDITIONAL INFORMATION RECEIVED ON 3/19/2025: DURING THE REVISION SURGERY ON (B)(6) 2022 AN AR-9564-2842-LAT ARTHREX UNIVERS REVERS GLENOSPHERE, AN AR-9563-16 UNIVERS REVERS PERIPHERAL SCREW, TWO AR-9563-24 UNIVERS REVERS PERIPHERAL SCREW, AN AR-9562-32NL UNIVERS REVERS PERIPHERAL SCREW, AN AR-9502F-42RCPC ARTHREX UNIVERS REVERS SUTURE CUP, AN AR-9501-11P ARTHREX UNIVERS REVERS HUMERAL STEM, AN AR-9550-15 ARTHREX UNIVERS REVERS SPACER, AND AN AR-9503L-06C ARTHREX UNIVERS REVERS HUMERAL INSERT WAS REMOVED. THE CASE WAS COMPLETED WITH NEW ARTHREX UNIVERS REVERS IMPLANTS.
Patient problems: Bone Fracture(s)
MAUDE report 21774128 ↗
Other PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED devices
- DJO SURGICAL 509-02-032Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED364 reports
- DELTA XTEND 130790036Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED171 reports
- DELTA XTEND 130770018Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED159 reports
- TRIGEN 71118200Smith & Nephew, Inc. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED123 reports
- DJO SURGICAL 509-02-432Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED119 reports
- DELTA XTEND 130738206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED116 reports
- COMPREHENSIVE SHOULDER SYSTEM 113633Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED2 recalls4 reports
- DELTA XTEND 130742206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED99 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 16, 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