Arthrex® AR-9502RSCRecalls & reported problems
Arthrex, Inc. · UNIVERS REVERS REPLACEMENT CUP SCREW · 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 00888867305434), received between Aug 17, 2020 and Aug 17, 2020 — 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 16, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- Discomfort1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 17, 2020Break
IT WAS REPORTED THAT A PATIENT HAD UNDERGONE AN SHOULDER PROCEDURE (B)(6) 2019. DUE TO UPPER ARM/ BICEPS TENDON PAIN AND DISCOMFORT THE ORIGINAL SURGEON PERFORMED A REVISION RTSA PROCEDURE (B)(6) 2020 AT THE SAME FACILITY. DURING THE REVISION PROCEDURE WHILE ATTEMPTING TO REMOVE THE CUP SCREW FROM THE ORIGINAL PROCEDURE THE DRIVER TIP TWISTED AND THE SCREW STRIPPED. SALES REP STATES NOTHING OUT OF THE ORDINARY WAS NOTICED/ MENTIONED BY THE SURGEON DURING THE PROCEDURE. THE REVISION WAS COMPLETED WITHOUT ANY COMPLICATIONS. THE FOLLOWING DEVICES WERE EXPLANTED DURING THE REVISION AND EXCHANGED FOR LARGER SIZES: AR-9564-2436-LAT (LOT 18.01992), AR-9501-07P (LOT 18.02015), AR-9502F-36RCPC (LOT 170111405), AR-9503S-06 (LOT 19.00773), AR-9502RSC (LOT 18.01082). THE EXPLANTED DEVICES ARE NOT AVAILABLE TO RETURN FOR EVALUATION.
Patient problems: Discomfort; Pain
MAUDE report 10414458 ↗
Other PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED devices
- DJO SURGICAL 509-02-032Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED364 reports
- DELTA XTEND 130790036Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED171 reports
- DELTA XTEND 130770018Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED159 reports
- TRIGEN 71118200Smith & Nephew, Inc. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED123 reports
- DJO SURGICAL 509-02-432Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED119 reports
- DELTA XTEND 130738206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED116 reports
- COMPREHENSIVE SHOULDER SYSTEM 113633Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED2 recalls4 reports
- DELTA XTEND 130742206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED99 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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