Hip Instruments 01.15.10.0190Recalls & reported problems
Medacta International SA · AMIS Mobile Leg Positioner 2.0 Frame · Class 1
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07630040735773), received between Aug 23, 2019 and Mar 7, 2024 — classified as 6 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (3 reports).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Fracture3
- Appropriate Device Problem Term/Code Not Available1
- Insufficient Device Problem Information1
Patient problems
- Bone Fracture(s)7
- Insufficient Information1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 7, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
BONE FRACTURE OCCURRED DURING THE EXTERNAL ROTATION OF THE LEG WITH THE AMIS LEG POSITIONER. NO ADDITIONAL TREATMENT WAS PERFORMED AND THE SURGERY WAS COMPLETED SUCCESSFULLY. (B)(6) YEAR-OLD PATIENT WITH POOR BONE QUALITY. IT IS UNKNOWN WHETHER OR NOT THE SURGEON WILL FIX THE FRACTURE.
Patient problems: Bone Fracture(s)
MAUDE report 18854200 ↗MalfunctionOct 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use 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.
Patient problems: Bone Fracture(s)
MAUDE report 18018919 ↗InjuryMar 29, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
DURING THE PRIMARY HIP SURGERY ON (B)(6) 2023, WHEN THE SURGEON WAS EXTERNALLY ROTATING THE LEG IN THE AMIS LEG POSITIONER, THE PATIENT HAD A TIBIAL SPIRAL FRACTURE. THE SURGEON CONTINUED WITH THE CASE AND IT WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2023, THE SURGEON IMPLANTED A NAIL TO HELP WITH THE FRACTURE. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT HAD NOT BEEN PUTTING ANY WEIGHT ON THIS LEG FOR 2 YEARS. THE PATIENT IS A SMOKER AGED IN LATE 70'S WITH A SMALL BODY/STATURE. DUE TO HER IMMOBILITY, SHE HAD 40 DEGREE FLEXION CONTRACTURE. WHEN FINISHING THE ACETABULUM, DOING EXTERNAL ROTATION, HER KNEE WAS SO STIFF AND WOULDN'T ROTATE AND HER TIBIA SPIRAL FRACTURE HAPPENED.
Patient problems: Bone Fracture(s)
MAUDE report 16634057 ↗InjuryMay 17, 2022Fracture
SPIRAL FRACTURE FROM THE CENTER TO THE DISTAL PART OF THE TIBIAL DIAPHYSIS DURING EXTERNAL ROTATION 130-150 WITH LEG POSITIONER. OSTEOSYNTHESIS HAS BEEN PERFORMED WITH INTRAMEDULLARY NAILS ON APRIL 20. THE PATIENT BONE QUALITY IS POOR.
Patient problems: Insufficient Information
MAUDE report 14426901 ↗InjuryFeb 18, 2021Adverse Event Without Identified Device or Use Problem
DURING THE AMIS SURGERY, AT HIP REDUCTION PHASE THE PATIENT TIBIA AND FIBULA FRACTURED. THE SURGEON FIXED THE FRACTURE AND FINISHED THE SURGERY. THE PATIENT (FEMALE,(B)(6)) WAS OSTEOPHOROTIC AND HAD AN INTESTINE TUMOR (UNDER CHEMI TREATMENT).
Patient problems: Bone Fracture(s)
MAUDE report 11341588 ↗InjuryAug 6, 2020Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS DIAGNOSED WITH AN ANKLE FRACTURE AFTER AMIS SURGERY. THE FRACTURE WAS NOT DIAGNOSED AT SURGERY, IT WAS SEEN AFTER A COUPLE OF DAYS WHEN A HOLE LEG X-RAY WAS MADE. THE SURGEON TOLD ME, THAT HE THINKS THAT THE FOOT WAS NOT PROPERLY FIXED IN THE AMIS SHOE, ALSO THE PATIENT IS VERY SMALL WITH A SMALL FOOT AND SHE WAS VERY CONTRACT AT THE HIP. HE DID NOT NEED TO OPERATE THE FRACTURE IT IS TREATED CONSERVATIVE.
Patient problems: Bone Fracture(s)
MAUDE report 10372283 ↗InjuryMar 9, 2020Fracture
AFTER THE INSERTION OF THE TRIAL FEMORAL STEM AND POSITION OF THE HYPEREXTENSION ON THE AMIS MOBILE LEG POSITIONER, THE FRACTURE FROM THE GREATER TROCHANTER TO LESSER TROCHANTER HAS OCCURRED. THE SURGEON FIXED THE FRACTURE WITH THE CABLE.
Patient problems: Bone Fracture(s)
MAUDE report 9805215 ↗InjuryAug 23, 2019Fracture
PER-OPERATIVE TIBIA FRACTURE AROUND DIAPHYSIS DISCOVERED AFTER THE THA SURGERY WITH AMIS MOBILE LEG POSITIONER. THE CAUSE OF THE FRACTURE MIGHT BE CONSIDERED THAT THE OPERATION PROCEDURE OF EXTERNAL ROTATION AND HYPEREXTENSION BY THE LEG POSITIONER. THE PATIENT KNEE WAS IMMOBILIZED WITH THE CASTS. NO ADDITIONAL SURGERY WAS PLANNED.
Patient problems: Bone Fracture(s)
MAUDE report 8925251 ↗
Other Table, Operating-Room, Mechanical devices
- HIP Instruments 01.15.10.0315Medacta International SA · Table, Operating-Room, Mechanical3 reports
- MULTILOK TABLE BASE 0302-001Mizuho Orthopedic Systems, Inc. · Table, Operating-Room, Mechanical2 reports
- Hip Instruments 01.15.10.0071Medacta International SA · Table, Operating-Room, Mechanical1 report
- Hip Instruments 01.15.10.0321Medacta International SA · Table, Operating-Room, Mechanical1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.