Hip Instruments 01.15.10.0071Recalls & reported problems
Medacta International SA · AMIS Shoe · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630040734950), received between Jul 16, 2019 and Jul 16, 2019 — classified as 1 malfunction.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Bone Fracture(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 16, 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 MEDACTA OLD STYLE BOOT HAS BEEN USED.
Patient problems: Bone Fracture(s)
MAUDE report 8793308 ↗
Other Table, Operating-Room, Mechanical devices
- Hip Instruments 01.15.10.0190Medacta International SA · Table, Operating-Room, Mechanical8 reports
- 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 01.15.10.0321Medacta 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.