Arthrex® AR-9100-12PRecalls & reported problems
Arthrex, Inc. · UNIVERS II HUMERAL STEM 12MM · 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 00888867057166), received between Nov 9, 2018 and Nov 9, 2018 — 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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 9, 2018Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED ON (B)(6) 2018 DUE TO AN NON-REPAIRABLE ROTATOR CUFF REPAIR. ADDITIONAL INFORMATION OBTAINED (B)(6) 2018: THE PATIENT WAS PARTICIPATING IN AN ECLIPSE TSA STUDY PROGRAM. THE DEVICES LISTED BELOW WERE IMPLANTED ON (B)(6) 2016. THE SURGEON REPORTED THAT THE ROTATOR CUFF WAS TORN AND APPEARED TO BE FROM TRAUMA, BUT PATIENT DENIED. THE SUBJECT RECEIVED A REVERSE DEVICE AFTER THE ORIGINAL DEVICES WERE EXPLANTED. THE PATIENT SUBJECT WAS TERMINATED FROM THE STUDY UPON DEVICE REMOVAL. THE DEVICES WERE DISCARDED PRIOR TO ARTHREX BEING NOTIFIED AS IT WAS THOUGHT THAT THE DEVICES DID NOT NEED TO BE RETURNED AS THEY DID NOT FEEL IT WAS A DEVICE MALFUNCTION.
Patient problems: No Code Available
MAUDE report 8054574 ↗
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- 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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