Arthrex® AR-9508-39Recalls & reported problems
Arthrex, Inc. · UNIVERS REVERS HUMERAL CUP REAMER -M/39 · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867061552), received between Jun 6, 2024 and Jun 6, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (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
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 6, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
ON 09/30/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT THE SURGEON HAD DIFFICULTY INSERTING THE AR-9508-39 REAMER OVER THE 135 +2 RIGHT REAMER GUIDE PIN. WHEN USING THE REAMER ON POWER, IT APPEARED TO CATCH AND TORQUE ON THE GUIDE PIN. A NEW TRAY WAS OPENED AND ANOTHER AR-9508-39 WAS USED TO COMPLETE THE CASE. POST-SURGERY INSPECTION APPEARS TO SHOW SOME WEAR MARKS ON THE INTERNAL PORTION OF THE 39MM REAMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19476083 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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