HIP Instruments 01.22.10.0151Recalls & reported problems
Medacta International SA · Proximal Body Handle · Class 1
All models of Hip Instruments (48)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630040739252), received between Mar 28, 2024 and Jun 5, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (1 report).
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
- Material Deformation1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 5, 2025Material Twisted/Bent; Material Twisted/Bent
AFTER PROXIMAL BODY INSERTION, THE SURGEON WASN'T HAPPY WITH THE STEM VERSION AND WANTED TO CHANGE IT. THE PROXIMAL BODY HANDLE WAS SCREWED ON THE NECK AND THE SMALL ROD PLACED INSIDE WITH THE T-HANDLE. BUT IT WAS IMPOSSIBLE TO REMOVE THE PROXIMAL BODY BECAUSE THE HANDLE WAS STARTING TO BEND. THE SURGEON CHANGED THE CUP TO A DUAL MOBILITY TO COMPENSATE FOR THE VERSION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22149349 ↗MalfunctionMar 28, 2024Material Deformation; Material Deformation
DURING A REVISION SURGERY (DUE TO THE DISLOCATION OF THE BIPOLAR HEAD FROM THE ACETABULAR), AFTER COMPLETING THE ACETABULAR WORK, THE SURGEON ATTEMPTED TO DISASSEMBLE THE PROXIMAL BODY FROM THE DISTAL STEM, BECAUSE HE WANTED TO REVISE ALSO THE PROXIMAL STEM TO GIVE MORE STABILITY TO THE ARTICULATION. THE PROXIMAL BODY COULD NOT BE DISASSEMBLED AND THE DISASSEMBLY ROD AND THE PROXIMAL BODY HANDLE WERE DEFORMED. FOLLOWING THIS ATTEMPT, THEY USED THE BACKUP HANDLE AND ANOTHER DISASSEMBLY ROD, AND AGAIN THE COMPONENTS COULDN'T BE UNCOUPLED. AT THIS POINT, THEY ATTEMPTED TO BACK OFF THE BODY WITH THE STEM REMOVAL INSTRUMENTS BUT IT WOULD NOT RELEASE. THE SURGEON THEN DECIDED TO LEAVE THE M-VIZION STEM. ONLY 5 MINUTES DELAY REPORTED. THE SURGEON WAS SATISFIED WITH THE RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18993010 ↗
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 reports
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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