Arthrex® AR-9100-05SRecalls & reported problems
Arthrex, Inc. · UNIVERS APEX HUMERAL STEM, SIZE 5 · 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 00888867228214), received between Jan 30, 2023 and Jan 30, 2023 — 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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Patient Device Interaction Problem1
Patient problems
- Loss of Range of Motion1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 30, 2023Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Patient Device Interaction Problem
ON JANUARY 9TH, 2023, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A SEVERE COMPLICATION OCCURRED OF A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY. PATIENT UNDERWENT TOTAL SHOULDER PROCEDURE ON (B)(6) 2021, IN WHICH THE ARTHREX UNIVERS APEX IMPLANT SET WAS USED. A YEAR LATER, PATIENT COMPLAINT OF PAIN AND MOTION LIMITATION. ON (B)(6) 2022, A REVISION TOOK PLACE FOR ARTHROSCOPIC DEBRIDEMENT AND NERVE RELEASE OF THE SUPRASCAPULAR NOTCH. NO ADDITIONAL INFORMATION HAS BEEN REPORTED AS OF NOW. ADDITIONAL INFORMATION RECEIVED ON 1/10/2023: THE FOLLOWING ARTHREX PRODUCTS WERE IMPLANTED DURING THE ORIGINAL PROCEDURE: ARTHREX UNIVERS LL HUMERAL HEAD, PART NUMBER AR-9140-17P, LOT170024021. ARTHREX UNIVERSE APEX HUMERAL STEM, PART NUMBER AR-9100-05S, LOT 10193799. UNIVERS VAULTLOCK GLENOID SMALL PART NUMBER AR-9106-01, LOT1027262023. ALL REMAIN IMPLANTED IN THE PATIENT, AS NOTHING WAS EXPLANTED DURING THE REVISION SURGERY. BOTH SURGERIES WERE PERFORMED BY THE SAME SURGEON AT THE SAME FACILITY.
Patient problems: Loss of Range of Motion; Pain
MAUDE report 16263386 ↗
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- Alliance® SBGL3007Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED162 reports
- DELTA XTEND 130760138Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED146 reports
- DELTA XTEND 130790030Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED132 reports
- DJO SURGICAL 509-00-436Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented124 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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