HIP INSTRUMENTS
Received Apr 16, 2025 · Event occurred Mar 21, 2025
Report 3005180920-2025-00365 · MDR key 21847223
Device
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
78 YR · Male
- Bone Fracture(s)
- Bone Fracture(s)
Narrative
Additional Manufacturer Narrative
VISUAL INSPECTION PERFORMED BY MEDACTA R&D HIP PROJECT MANAGER: TEST ON THE SHOE AND LEG POSITIONER USED IN THE SURGERY OF THE COMPLAINT: - THE PIN OF THE SHOE WAS DAMAGED ON THE BLACK PLASTIC PART AND UNSCREWED BY SOMEONE OUTSIDE MEDACTA FACILITIES. - THE COMPLAINT SHOE/TABLE DISCONNECTION ROOT CAUSE IS THIS UNSCREWING THAT HAS REDUCED THE PIN LENGTH AND ALLOWED THE SHOE PIN TO COME OUT FROM THE RETAINING HOLE PRESENT ON THE LEG POSITIONER PART IN CONNECTION WHEN THE PATIENT'S LEG IS PUT ON EXTERNAL ROTATION. TEST DONE BETWEEN A COMPLIANT SHOE AND THE SAME LEG POSITIONER USED IN THE SURGERY OF THE COMPLAINT: MAKING SOME TESTS BETWEEN A COMPLIANT SHOE WITH THE SAME LEG POSITIONER USED IN THE SURGERY OF THE COMPLAINT, WE DID NOT NOTICE ANY PROBLEM OR UNEXPECTED DISCONNECTION. THE PIN OF THE SHOE IS FIXED WITH A THREADED LOCKER (FIXED WITH LOCTITE) TO MAKE IT DIFFICULT TO UNSCREW THE PIN AND AVOID UNEXPECTED UNSCREWING. FUNCTIONAL CONTROLS ARE ALWAYS MADE BY THE MEDACTA CQ DEPARTMENT ON EVERY SHOE BEFORE SHIPMENT. CONCLUSIONS: AS REPORTED IN THE INVESTIGATION THE ROOT CAUSE OF THE EVENT IS THAT THE PIN OF THE SHOE WAS DAMAGED ON THE BLACK PLASTIC PART AND UNSCREWED BY SOMEONE OUTSIDE MEDACTA FACILITIES LEADING TO A POOR CONNECTION STABILITY WITH THE AMIS MOBILE LEG POSITIONER. FUNCTIONAL CONTROLS ARE ALWAYS MADE BY THE MEDACTA CQ DEPARTMENT ON EVERY SHOE BEFORE SHIPMENT.
Additional Manufacturer Narrative
BATCH REVIEW PERFORMED ON 31 MARCH 2025: LOT 2158139: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-DEC-2021. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED ON THE SAME LOT DURING THE PERIOD OF REVIEW.
Description of Event or Problem
DURING SURGERY, WHILE EXTERNAL ROTATING THE FOOT WHEN THE LEG WAS DOWN, THE BOOT SLIPPED AWAY FROM THE AMIS MOBILE LEG POSITIONER. THIS WAS DUE TO THE BOOT CLIPPING MECHANISM TO THE AMIS MOBILE LEG POSITIONER. A BONE FRACTURE WAS DETECTED IN PER-OP, BUT THE SURGEON IS NOT SURE IF THIS WAS DUE TO THE BOOT SLIPPING AWAY OR TO THE PREPARATION OF THE FEMUR WITH COMPETITOR BROACHES. THE SURGERY WAS COMPLETED SUCCESSFULLY.