Arthrex® AR-9165-25Recalls & reported problems
Arthrex, Inc. · UNIVERSAL GLENOID - CENTRAL SCREW 25MM · 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 00888867057944), received between Sep 2, 2020 and Sep 2, 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
- Corroded1
- Positioning Problem1
- Unstable1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 2, 2020Break; Corroded; Unstable; Positioning Problem
IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE AN INITIAL REVISION SURGERY ON (B)(6) 2018 DURING WHICH THE FOLLOWING DEVICES WERE IMPLANTED: AR-9120-01 (LOT 170115215), AR-9145-36 (LOT 170037012), AR-9145-30 (LOT 170057712), AR-9504S-04 (LOT 170091414), AR-9555-09 (LOT 2501367202), AR-9503S-03C (LOT 2501374603), AR-9165-25 (LOT 2501357504). THE (B)(6) 2018 PROCEDURE WAS A REVISION OF ARTHREX PRODUCTS BECAUSE THE PATIENT HAD GLENOID INSTABILITY DUE TO BASEPLATE PLACEMENT ON THE PRIMARY. IT IS UNKNOWN IF THE 2018 REVISION WAS EVER REPORTED TO ARTHREX AS NO DETAILS FROM THE ORIGINAL SURGERY ARE KNOWN TO SEARCH/MATCH PART NUMBERS. THE IMPLANTS PUT IN ON (B)(6) 2018 WERE DONE SO IN A COMPROMISED GLENOID WITH POOR BONE QUALITY. THE PERIPHERAL SCREWS BROKE AND LED TO BASEPLATE FAILURE. THE GLENOSPHERE REMAINED ENGAGED IN THE BASEPLATE. THERE WAS SIGNIFICANT CORROSION OF THE HUMERAL POLY INSERT. THE GLENOID COMPONENTS FAILED NEARLY TWO YEARS AGO BUT THE PATIENT WAITED UNTIL (B)(6) 2020 TO HAVE A REVISION SURGERY. THE SALES REPRESENTATIVE REPORTED THAT THE SURGEON ATTRIBUTED THE FAILURE TO PUTTING THE BASEPLATE ON HER ORIGINAL REVERSE PROCEDURE TOO SUPERIOR ON THE FACE OF THE GLENOID WITH S
Patient problems: No Code Available
MAUDE report 10482869 ↗
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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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