Arthrex® AR-5400-10Recalls & reported problems
Arthrex, Inc. · SIZE 10 LEG, GLENOID TARGETER · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867315372), received between Jun 4, 2024 and Mar 26, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Defective Device” (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.
Reports received per month
Most reported problems
Device problems
- Defective Device1
- Physical Resistance/Sticking1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 26, 2025Defective Device; Defective Device
ON 03/03/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-5400-02 VIP¿ GLENOID TARGETER HANDLE SLID EVEN THOUGH BOTH NUTS WERE SECURED TIGHTLY. AR-5400-04 VIP¿ GLENOID TARGETER LOCKING NUT, AND A SECOND NUT FROM THE AR-4500-S SET. THIS OCCURRED DURING A REVERSE SHOULDER ARTHROPLASTY ON (B)(6) 2025. ADDITIONAL INFORMATION WAS PROVIDED ON 03/04/2025 WHERE THE SALES REPRESENTATIVE STATED THE ARMS THAT DIDN'T HOLD IN PLACE WERE 10,12,15,18, 25. CLARIFICATION: IT WAS REPORTED THAT THE TARGETER ARMS, AR-5400-10, AR-5400-12, AR-5400-15, AR-5400-18, AND AR-5400-25 WERE SLIDING ON THE HANDLE, DESPITE BOTH NUTS BEING SECURELY TIGHTENED.
Patient problems: Insufficient Information
MAUDE report 21696798 ↗MalfunctionJun 4, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
ON 11/17/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-5400-10 GLENOID TARGETER THE SIZE 10 LEG JAMMED INTO LETTER D'S SLOT ON THE GLENOID TARGETER SHAFT. OTHER SIZED LEGS WERE ABLE TO SLIDE IN AND OUT FREELY OF LETTER D'S SLOT ON THE GLENOID TARGETER SHAFT. THIS OCCURRED AT THE BEGINNING OF A REVERSE TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2022 SO THE 11 LEG WAS SUBSTITUTED IN AND THE CASE CARRIED ON SUCCESSFULLY. THERE WAS NO PATIENT EFFECT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19459161 ↗
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- Alliance® SBGL3007Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED162 reports
- DELTA XTEND 130760138Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED146 reports
- DELTA XTEND 130790030Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED132 reports
- DJO SURGICAL 509-00-436Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented124 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.
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