HIP Instruments 01.39.10.0033Recalls & reported problems
Medacta International SA · Calcar Reamer Large Zimmer Hall · 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
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630040763790), received between Jan 12, 2024 and Jun 27, 2024 — classified as 3 injuries.
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
- Appropriate Device Problem Term/Code Not Available2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Bone Fracture(s)3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
FEMUR FRACTURE CAUSED WHEN THE SURGEON WAS USING THE LARGE CALCAR REAMER AND THE BROACH. THE SURGEON CABLED THE FRACTURE COMPLETING SUCCESSFULLY THE CASE. THE STEM IMPLANTED WAS AN AMISTEM-P.
Patient problems: Bone Fracture(s)
MAUDE report 19621813 ↗InjuryJun 21, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
DURING CALCAR REAMING THE, CALCAR REAMER CAUGHT ON X-ACTA BROACH WHICH CAUSED IT TO TORQUE AND RESULTED IN A LONGITUDINAL PROXIMAL FEMUR FRACTURE. CABLES WERE USED TO REDUCE THE FRACTURE. THE SURGEON WAS USING AXIAL FORCE WITH THE CALCAR REAMER ON POWER. HE SUSPECTS THE FORCE MAY HAVE BEEN OFF AXIS AND THE TEETH OF THE CALCAR REAMER CAME INTO CONTACT WITH THE PROXIMAL PART OF THE BROACH. THE INSTRUMENTS WERE ALL IN GOOD CONDITION WITH NO DEFORMATION/ DAMAGE PRESENT.
Patient problems: Bone Fracture(s)
MAUDE report 19582673 ↗InjuryJan 12, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
DURING THE PRIMARY HIP SURGERY, A FEMORAL BONE FRACTURE OCCURRED WHILE REAMING THE CALCAR WITH THE CALCAR REAMER LARGE ZIMMER HALL. THE SURGERY WAS COMPLETED SUCCESSFULLY. NOTHING WAS DONE TO THE FRACTURE, AS IT WAS "CONTAINED" AND THE SURGEON DID NOT FEEL THAT A CABLE OR PLATE WAS NECESSARY.
Patient problems: Bone Fracture(s)
MAUDE report 18501924 ↗
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
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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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