Hip Instruments 01.32.10.1156Recalls & reported problems
Medacta International SA · Impaction Plate DMH · 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 07630040753692), received between Apr 4, 2019 and Jul 10, 2019 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (2 reports).
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
- Material Fragmentation2
- Solder Joint Fracture1
Patient problems
- No Known Impact Or Consequence To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 10, 2019Material Fragmentation; Material Fragmentation
DURING THE PRIMARY HIP SURGERY, AND AFTER IMPACTING THE CUP, THE SURGEON TRIED TO UNSCREW THE HANDLE AND IT WOULD NOT RELEASE. AFTER CONTINUOUSLY TRYING TO RELEASE THE HANDLE, THE PLATE BROKE INTO MANY PIECES. FRAGMENTS FELL INTO THE PATIENT AND WERE REMOVED. THERE WAS A 5-MINUTE DELAY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8775348 ↗MalfunctionApr 25, 2019Material Fragmentation; Material Fragmentation
DURING THE PRIMARY HIP SURGERY AND AFTER IMPACTING THE CUP, IT WAS DISCOVERED THAT THE IMPACTION PLATE HAD BROKEN DURING IMPACTION. NO FRAGMENTS FELL INTO THE PATIENT'S SURGICAL WOUND AND THERE WAS NO DELAY IN THE CASE. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8548600 ↗MalfunctionApr 4, 2019Solder Joint Fracture; Solder Joint Fracture
DURING THE PRIMARY HIP SURGERY AND AFTER IMPACTING THE CUP, IT WAS DISCOVERED THAT THE IMPACTION PLATE BROKE AND A FRAGMENT FELL INTO THE PATIENT. THE SURGEON WAS ABLE TO REMOVE THE FRAGMENT AND THE CASE WAS DELAYED BY 3-MINUTES. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8482792 ↗
Other Orthopedic Manual Surgical Instrument devices
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- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- 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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