AMIS MOBILE LEG POSITIONER 2.0 FRAME
Received Oct 27, 2023 · Event occurred Aug 22, 2023
Report 3005180920-2023-00817 · MDR key 18018919
Device
Generic name
Hip Instrument
Manufacturer
Medacta International SaCatalog number
01.15.10.0190
Lot number
1656238
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Bone Fracture(s)
- Bone Fracture(s)
Narrative
Description of Event or Problem
THE PROXIMAL FEMUR FRACTURE OCCURRED DURING THE SURGERY WITH THE AMIS LEG POSITIONER UPON TRIAL REDUCTION (INTERNAL ROTATION OF THE FOOT). THE SURGEON CABLED THE FRACTURE AND THE SURGERY WAS COMPLETED SUCCESSFULLY. SURGEON SAYS IT WAS THE PRESENCE OF OSTEOPHYTES THAT COULD CAUSED THE FRACTURE AND HALF THE MEDIAL CALCAR CAME OFF DURING PREPARATION AND REMOVAL OF FEMORAL BONE HEAD THAT GREATLY WEAKENED THE INTEGRITY OF THE PROXIMAL FEMUR.
Additional Manufacturer Narrative
BATCH REVIEW PERFORMED ON (B)(6) 2023. LOT 1656238: 15 ITEMS MANUFACTURED AND RELEASED ON 08-MARCH-2018. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED ON THE SAME LOT.