Arthrex® AR-9502-36RCPCRecalls & reported problems
Arthrex, Inc. · UNIVERS REVS CUP,36/+ 2MM RT OFFSET CTD · 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 00888867061149), received between Sep 24, 2018 and Sep 24, 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
- Fever1
- Pain1
- Rash1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 24, 2018Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY A NURSE AT AN ALLERGIST'S OFFICE THAT A PATIENT HAD RIGHT SHOULDER-REVERSE TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2017. DURING THE SURGERY THE FOLLOWING PRODUCTS (LOT NUMBERS UNKNOWN) WERE IMPLANTED IN THE PATIENT: AR-9501-06P UNIVERSAL REVERSE HUMERAL STEM, AR-9502-36RCPC UNIVERSAL REVERSE CUP, AR-9145-30 UNIVERSAL GLENOID PERIPHERAL LOCKING SCREW (QTY UNKNOWN) AND AR-9120-01 UNIVERSAL GLENOID BASEPLATE SMALL. IT HAS BEEN REPORTED THAT PATIENT BEGAN HAVING REACTION TYPE SYMPTOMS, LOW GRADE TEMPERATURE - PAIN - RASH, ALMOST IMMEDIATELY AFTER THE PROCEDURE WHICH HAS PERSISTED. NO CULTURES HAVE BEEN TAKEN HOWEVER BLOOD WORK TAKEN SHOWED NO INFECTION INDICATED. PATIENT IS BEING SEEN BY AN ALLERGIST TO ATTEMPT TO DETERMINE IF PATIENT MAY HAVE AN ALLERGY TO THE ARTHREX IMPLANTS. MATERIAL COMPOSITION OF THE PRODUCTS HAS BEEN PROVIDED TO THE REPORTER.
Patient problems: Fever; Pain; Rash
MAUDE report 7901933 ↗
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- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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