HIP Instruments 01.15.10.0263Recalls & reported problems
Medacta International SA · AMIS Cup Impactor Terminal-M10 · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630040736015), received between Feb 7, 2019 and Jun 23, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Complete Blockage” (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.
Most reported problems
Device problems
- Complete Blockage1
- Difficult to Remove1
- Failure to Disconnect1
- Mechanical Jam1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 23, 2022Mechanical Jam; Mechanical Jam
TERMINAL FOR CUP IMPACTOR AND VERSAFITCUP CC TRIO COLD WELDING DURING THE SURGERY, A BACK UP SHELL OF THE SAME SIZE WAS OPEN AND USED WITHOUT SUCCESS BECAUSE THE PRESS FIT IN THE BONE WASN'T GOOD. DUE TO THIS AN ADDITIONAL ACETABULAR BONE REAMING WAS NECESSARY AND A NEW CUP SIZE 56 WAS FINALLY IMPLANTED WITH SUCCESS. 1,30H DELAY IN THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14787360 ↗MalfunctionSep 6, 2019Failure to Disconnect
AFTER THE SURGEON IMPACTED THE CUP, IT WAS NOT POSSIBLE TO DISCONNECT THE TERMINAL CUP IMPACTOR. HE HAD TO EXPLANT THE CUP AND USE A NEW ONE WITH THE STRAIGHT CUP IMPACTOR. THERE WAS A 5 MINUTES DELAY
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8969653 ↗MalfunctionFeb 7, 2019Complete Blockage; Difficult to Remove
DURING THE SURGERY THE TERMINAL FOR CUP IMPACTION REMAINED BLOCKED IN THE CUP. THE SURGEON DIDN'T HAVE THE 01.15.10.0293 SCREWDIRVER WITH T-HANDLE TO REMOVE THE TERMINAL FROM THE CUP; HE TRIED TO RELEASE THE ADAPTER FOR ABOUT 10 MINUTES. FINALLY THE SURGEON USED A BACK-UP IMPLANT AND INSTRUMENT COMPLETING SUCCESSFULLY THE SURGERY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8315264 ↗
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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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