EASYTECH
Received May 22, 2026 · Event occurred Mar 26, 2026
Report 3014128390-2026-00018 · MDR key 25260485
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
53 YR · Unknown
- Implant Pain
Narrative
Description of Event or Problem
REVISION SURGERY OCCURRED ON (B)(6) 2026. ALL REQUIRED INFORMATION WAS RECEIVED ON 15-MAY-2026. THE REVISION SURGERY HAPPENED 196 DAYS AFTER THE PRIMARY SURGERY WHICH OCCURRED ON (B)(6) 2025. NO FALL OR OTHER TRAUMA REPORTED. BASED ON COMPARING USAGE FORMS ONLY OFFSET HEAD 43X19 AND DOUBLE TAPER TA6V +0MM 0°WAS EXPLANTED DUE TO PAIN. THE PATIENT REPORTED TIGHTNESS AND PAIN DUE TO THE THICKNESS OF THE HEAD. THESE PARTS WERE REPLACED WITH OFFSET HEAD COCR/TIN 39X15 AND DOUBLE TAPER TA6V +0MM 0°. EASYTECH ANCHOR BASE TA6V Ø34 MM CEMENTLESS TI/HA WAS NOT REPLACED.
Additional Manufacturer Narrative
REVISION OCCURRED APPROXIMATELY 196 DAYS AFTER THE PRIMARY SURGERY DUE TO PAIN. NO ACTUAL, IMPLIED, OR SUSPECT LINK TO FX PRODUCT.