HIP Instruments 01.15.10.0315Recalls & reported problems
Medacta International SA · AMIS Shoe · Class 1
All models of Hip Instruments (48)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630040736206), received between Jul 19, 2019 and Sep 18, 2024 — classified as 3 injuries.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Bone Fracture(s)3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
FIBULA FRACTURE DETECTED 5 DAYS AFTER AMIS SURGERY. NO ADDITIONAL SURGERY PLANNED. THE SURGEON REPORTS THAT THE FRACTURE HAPPENED WHILE THE PATIENT'S FOOT WAS IN THE AMIS SHOE.
Patient problems: Bone Fracture(s)
MAUDE report 20244206 ↗InjuryDec 3, 2021Adverse Event Without Identified Device or Use Problem
AN ANKLE BONE FRACTURE HAS BEEN DISCOVERED IN A PATIENT OPERATED WITH THE AMIS LEG POSITIONER. IT IS UNKNOWN IF THE FRACTURE HAPPENED DURING THE SURGERY, IT WAS DISCOVERED DURING THE RECOVERY PERIOD. THE PATIENT HAS NOW A SPLINT TO HOLD THE FRACTURE.
Patient problems: Bone Fracture(s)
MAUDE report 12922535 ↗InjuryJul 19, 2019Adverse Event Without Identified Device or Use Problem
3 WEEKS AFTER PRIMARY THE PATIENT COMPLAINED A LATERAL ANKLE INJURY (MINOR ANKLE FRACTURE). THE SURGICAL STEP IN WHICH THE TRAUMA HAS BEEN GENERATED IS UNKNOWN. DURING THE PRIMARY THE AMIS TABLE WITH AMIS BOOT HAS BEEN USED.
Patient problems: Bone Fracture(s)
MAUDE report 8807560 ↗
Other Table, Operating-Room, Mechanical devices
- Hip Instruments 01.15.10.0190Medacta International SA · Table, Operating-Room, Mechanical8 reports
- MULTILOK TABLE BASE 0302-001Mizuho Orthopedic Systems, Inc. · Table, Operating-Room, Mechanical2 reports
- Hip Instruments 01.15.10.0321Medacta International SA · Table, Operating-Room, Mechanical1 report
- Hip Instruments 01.15.10.0071Medacta International SA · Table, Operating-Room, Mechanical1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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