Arthrex® AR-9502-39RCPCRecalls & reported problems
Arthrex, Inc. · UNIVERS REVS CUP,39/+ 2MM RT OFFSET 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 00888867061170), received between Dec 14, 2016 and Dec 14, 2016 — classified as 1 injury.
The most frequently reported specific device problem is “Fitting 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.
Most reported problems
Device problems
- Fitting Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 14, 2016Fitting Problem
IT WAS REPORTED THAT CUP (B)(4), LOT 150006510, LINE (B)(4) COULD NOT BE MOUNTED ON SHAFT (B)(4), LOT 150023110, LINE (B)(4). SCREW COULD BE SCREWED IN, HOWEVER, CUP DID NOT FIT INTO THE NUT ON THE TOP OF THE SHAFT. SURGEON OPENED TWO ADDITIONAL CUPS TO USE THE SCREWS TO TRY TO FIX THE CUP TO THE SHAFT, HOWEVER, WITHOUT SUCCESS. SURGEON TRIED SEVERAL CUPS AND WAS FINALLY ABLE TO CONNECT AN (B)(4) CUP ON A (B)(4) SHAFT. SURGEON HAD TO DO A PARTIAL RESECTION AT THE HUMERUS WITH A RASP TO MAKE COMPONENTS FIT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6173250 ↗
Other shoulder prosthesis, reverse configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page