Arthrex® AR-13110R-02Recalls & reported problems
Arthrex, Inc. · CONTURLK FEM OS-TEOTOMY PLT RGHT L/XL · 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 00888867088306), received between Jan 13, 2025 and Jan 13, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Patient Device Interaction 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.
Reports received per month
Most reported problems
Device problems
- Patient Device Interaction Problem1
Patient problems
- Bone Fracture(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 13, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-13110R-02 CONTOURLOCK FEMORAL OSTEOTOMY PLATE HAD AN ISSUE DURING A DISTAL FEMORAL OSTEOTOMY (DFO) PROCEDURE. THE FIRST 6.5 CANCELLOUS SCREW WAS INSERTED INTO THE DISTAL CONDYLE. THEN, THE FIRST 4.5MM CORTICAL SCREW WAS PLACED INTO THE FIRST SHAFT HOLE PROXIMAL TO THE MOST DISTAL SHAFT HOLE. TWO ADDITIONAL 6.5MM CANCELLOUS SCREWS WERE PLACED IN THE DISTAL CONDYLE SCREW HOLES, LEAVING THE LOCKING HOLE UNOCCUPIED. A SECOND 4.5MM CORTICAL SCREW WAS INSERTED INTO THE SHAFT HOLE PROXIMAL TO THE PREVIOUSLY PLACED CORTICAL SCREW. THE SCREW INITIALLY ADVANCED SMOOTHLY BY HAND, BUT AS IT ENGAGED THE BUSHING, AN AUDIBLE CRACK WAS HEARD. X-RAY IMAGING REVEALED NO VISIBLE FRACTURE AT THAT TIME. THE NEXT PROXIMAL SHAFT HOLE WAS DRILLED USING THE SAME TECHNIQUE (CIRCUMFERENTIALLY OPENING THE NEAR CORTEX), AND A SECOND CRACK WAS HEARD DURING SCREW INSERTION. X-RAY IMAGING REVEALED A SPLIT IN THE FEMUR EXTENDING PROXIMALLY TOWARD THE HIP. THE MOST DISTAL SCREW HOLE IN THE SHAFT OF THE PLATE WAS THEN FILLED WITHOUT INCIDENT OR AUDIBLE CRACKING. A FINAL SCREW WAS PLACED IN THE MOST PROXIMAL HOLE OF THE PLATE. WHILE NO CR
Patient problems: Bone Fracture(s)
MAUDE report 21143836 ↗
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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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