Arthrex® AR-9501-09CPCRecalls & reported problems
Arthrex, Inc. · UNIVERS REVERS STEM, SIZE 9, CAP COATED · Class 2 · Implant
Data updated Oct 18, 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 00888867061033), received between Aug 6, 2025 and Aug 6, 2025 — 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Patient Device Interaction Problem1
Patient problems
- Metal Related Pathology1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 6, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT AFTER A PATIENT WAS TREATED IN 2013 WITH AN UNIVERS REVERS WITH A 36 SUTURE CUP AND A UNIVERSAL GLENOID (39 GLENOSPHERE). THE PATIENT HAD A GUT SURGERY RECENTLY AND STARTED FEELING UNWELL AND HAVING SHOULDER PAIN. THE PATIENT VISITED THE SURGEON WHOM THEN DISCOVERED THAT THERE WAS AN INFECTION IN THE RIGHT SHOULDER AND SAW COMPONENT LOOSENING AND WEAR IN THE CT SCAN. AT FIRST THE SURGEON REMOVED THE GLENOSPHERE AND SUTURE CUP WHICH WERE ALREADY LOOSE ON THE (B)(6) 2025 AND TOOK SAMPLES TO DETERMINE THE SOURCE OF THE INFECTION. THE SURGEON THEN REPORTED ON THE (B)(6) THAT EVERYTHING HAD TO BE REMOVED OUT DUE TO THE PATHOGEN BEING A MORE SERIOUS. UPON REMOVAL, THE SURGEON SAW A SEVERE METALLOSIS AND TISSUE CHANGES AROUND THE IMPLANT AND THE IMPLANT ITSELF WAS COMPLETELY WORN. IT WAS FURTHER REPORTED THAT THERE WAS NO REPORT OF A PATIENT ACCIDENT SUCH AS A FALL OR OTHER INJURY THAT MAY HAVE CAUSED THIS. ***UPDATE DW 21-JUL-2025 FURTHER CLARIFICATION WAS PROVIDED THAT THERE WERE 2 REVISIONS, THE FIRST ONE WAS PERFORMED ON THE (B)(6) AND A SECOND ONE ON (B)(6). THE FIRST REVISION WHICH WAS PERFORMED ON THE (B)(6) 2025 IS HANDLED IN CASE-(B)(4). THE FOLLOWING DEVICES
Patient problems: Metal Related Pathology
MAUDE report 22728824 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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