Arthrex® AR-9502-42CPCRecalls & reported problems
Arthrex, Inc. · UNIVERS REVS CUP,42/NEUTRAL CTD · 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 00888867061187), received between Sep 18, 2018 and Sep 18, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break1
- Physical Resistance/Sticking1
Patient problems
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2018Break; Physical Resistance/Sticking
IT WAS REPORTED THAT THE PATIENT REQUIRED A REVISION SURGERY. ORIGINAL DATE OF SURGERY WAS (B)(6) 2015. PER THE REP, THE AR-9502-42CPC BROKE IN HALF IN THE PATIENT WHEN HE WAS OPENING A BOTTLE OF WATER. THE REVISION WAS (B)(6) 2018. PARTS REMOVED WERE AR-9502-42CPC (LOT 12.714), AR-9550-12 (LOT 13.490) AND A ¿LINER¿ (NO PART # FOUND PER THE REP). THESE WERE REPLACED WITH AR-9502F-42CPC AND AR-9550-15. THE ORIGINAL CUP WAS DONE AT THE 135 DEGREE SLOT; THE REVISION WAS DONE AT THE 155 DEGREE SLOT. ORIGINAL SURGERY WAS DONE IN (B)(6), REVISION IN (B)(6) (DIFFERENT SURGEONS). ADDITIONAL INFORMATION OBTAINED 9/13/18: THE SALES REP HAS CONFIRMED THAT, PER THE SURGEON'S DECISION, THE DISTAL PART OF A SCREW, WHICH IS PART OF THE UNIVERSAL REVERSE CUP (AR-9502-42CPC), WAS STUCK IN THE 135 DEGREE HOLE OF THE UNIVERSAL REVERSE STEM THAT WAS NOT EXPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 7884924 ↗
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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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