Arthrex® AR-9501-04-135PRecalls & reported problems
Arthrex, Inc. · UNIVERS REVERS SIZE 4/33 MONOBLOCK STEM · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867439092), received between Mar 19, 2025 and Jul 30, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Defective Device” (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
- Defective Device1
- Positioning Failure1
Patient problems
- Failure of Implant1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 30, 2025Defective Device; Defective Device
ON 07/07/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9501-04-135P UNIVERS REVERS MONOBLOCK WAS LOOSE AND MISMATCHED IN SIZE. THIS WAS DISCOVERED DURING THE CASE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22665697 ↗InjuryMar 19, 2025Positioning Failure; Positioning Failure
ADDITIONAL INFORMATION RECEIVED ON 3/24/2025: AR-9564-2433-LAT ARTHREX UNIVERS REVERS GLENOSPHERE WERE EXPLANTED AS WELL. AR-9503-3336-3 UNIVERS REVERS COMBO HUMERAL INSERT WAS ATTEMPTED TO BE USED WITH THE SPACER, BUT IT WOULD NOT FIT, SO THE SURGEON TURNED TO AN AR-9503-3336-6C UNIVERS REVERS MODULAR GLENOID SYSTEM, CONSTRAINED COMBO HUMERAL INSERT. IT WAS ALSO REPORTED THAT THE SCREW FROM THE INITIAL AR-9504-06 UNIVERS REVERS SPACER WAS NOT WORKING AND AN AR-9502RSC UNIVERS REVERS REPLACEMENT CUP SCREW HAD TO BE USED.
Patient problems: Failure of Implant
MAUDE report 21641318 ↗
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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