Arthrex® AR-9501-09PRecalls & reported problems
Arthrex, Inc. · UNIVERS REVERS HUMERAL STEM, SIZE 9 · 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 00888867250413), received between Jun 25, 2024 and Jun 25, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (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
- Patient Device Interaction Problem1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 25, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
ON MAY 1ST, 2024, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A SEVERE COMPLICATION OCCURRED, RESULTING IN REVISION SURGERY TO A PATIENT LISTED IN THE SHOULDER ARTHROPLASTY REGISTRY. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2023 WITH CTA HEAD AND GLENOID GRAFTING. ADDITIONAL INFORMATION RECEIVED ON 5/16/2024. THE ORIGINAL TSA PROCEDURE WAS PERFORMED ON (B)(6) 2009. THE IMPLANTS USED IN THE ORIGINAL PROCEDURE WERE PRODUCTS FROM ANOTHER MANUFACTURING COMPANY. ON (B)(6) 2023, THE PATIENT WAS SEEN BY THE SURGEON DUE TO SEVERAL YEARS OF PAIN, AND IT WAS CONFIRMED VIA CT ARTHROGRAM THAT THE IMPLANTS HAD LOOSENED, AND THE PATIENT HAD SEVERAL ROTATOR CUFF TEARS. ON (B)(6) 2023, THE PATIENT WAS REVISED FROM A TSA TO A HEMIARTHROPLASTY IN WHICH THE SURGEON IMPLANTED A CTA HEAD AND GLENOID BONE GRAFT. SOON AFTER THE SURGERY, THE PATIENT STILL EXPERIENCED PAIN AND THE SURGEON SUGGESTED THE PATIENT MIGHT BE A CANDIDATE FOR A STATE PROCEDURE TO PUT IN A BASEPLATE. ON (B)(6) 2024, THE PATIENT UNDERWENT A SECOND REVISION SURGERY TO CONVERT THE HEMIARTHROPLASTY TO A REVERS TSA WITH A REPLANT OF THE GLENOID BASEPLATE. ADDITIONAL INFORMATION RECEIVED ON 5/29/2024: DURING THE REVISION
Patient problems: Pain
MAUDE report 19605308 ↗
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.
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