AMIS 01.15S.100 AMIS LEG POSITIONER 2.0 FRAME
Received Sep 7, 2023 · Event occurred Aug 8, 2023
Report 3005180920-2023-00678 · MDR key 17697148
Device
Generic name
Hip Leg Positioner
Manufacturer
Medacta International SaCatalog number
01.15S.100
Lot number
2155343
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Female
- Bone Fracture(s)
- Bone Fracture(s)
Narrative
Additional Manufacturer Narrative
BATCH REVIEW PERFORMED ON (B)(6) 2023. LOT 2155343: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-FEB-2022. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED ON THE SAME LOT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICA AFFAIRS DEPARTMENT: DURING PRIMARY THA, THE GREATER TROCHANTER WAS FRACTURED DURING THE EXTERNAL ROTATION WITH THE LEG POSITIONER. ACCORDING TO REPORT, THE BONE QUALITY OF THE PATIENT WAS WEAK, AND ALSO FROM THE RADIOGRAPHIC IMAGE THIS CAN BE CONFIRMED. IN ORDER TO FIX THE FRACTURE, PLATE AND CABLES WERE PLACED. THERE IS NO REASON TO SUSPECT A FAULTY DEVICE. OTHER DEVICES INVOLVED: STEM: AMISTEM C 01.18.700 AMISTEM-C SHORT NECK STD STEM SIZE 0 LOT. 2240295 LOT 2240295: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-DEC-2022. EXPIRATION DATE: 2027-NOV-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. AMISTEM-C SN IS NOT REGISTERED IN USA.
Description of Event or Problem
THE GREATER TROCHANTER WAS FRACTURED DURING THE EXTERNAL ROTATION WITH THE LEG POSITIONER. PLATE AND CABLES WERE PLACED TO FIX THE FRACTURE AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE BONE QUALITY WAS WEAK.