Hip Instruments 01.32.10.1070Recalls & reported problems
Medacta International SA · DM Cup impactor · Class 1
All models of Hip Instruments (48)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 07630040753616), received between Sep 9, 2026 and Sep 9, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2026Detachment of Device or Device Component
During a total hip arthroplasty, an Mpact Double Mobility Cup was implanted using impaction handle 01.32.10.1070 with the dedicated impaction plate. During impaction of the final cup, while the cup was still engaged with the impactor, the anvil of the impaction handle became loose and detached, falling onto the operating room floor. As the cup was already positioned in the acetabulum, the surgeon completed the impaction using the same handle without the anvil. The central rod was also removed, and the impaction plate was disengaged from the cup using pliers. The cup was successfully implanted; however, the impaction handle was damaged and could no longer be used. The event resulted in an approximately 30-minute surgical delay, with a total surgery time of 130 minutes.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50692273 ↗
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- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- 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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