Hip Instruments 01.15.10.0321Recalls & reported problems
Medacta International SA · MBOOT Kit 10 pieces · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630040728027), received between Nov 25, 2021 and Nov 25, 2021 — classified as 1 injury.
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.
InjuryNov 25, 2021Adverse Event Without Identified Device or Use Problem
A FIBULA 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 12874314 ↗
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 01.15.10.0071Medacta 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.