MyKnee NextAR Tibial Distal Cutting Block Efficiency 15.1242Recalls & reported problems
Medacta International SA · MyKnee NEXTAR Tibia Distal Cutting Block - CT - GMK – Right Medial - #2 · Class 2
Data updated Oct 18, 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 07630971271722), received between Mar 28, 2025 and Mar 28, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Inadequacy of Device Shape and/or Size1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 28, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
MEDACTA AUSTRALIA SENT THE INCORRECT GUIDES S_BUR_RSK_AL_19021938 (195373K), WHICH WERE USED DURING THE SURGERY, INSTEAD OF S_BUR_RSK_AL_26091945 (210276K). ALL TIBIAL AND FEMORAL CUTS WERE PERFORMED USING THE INCORRECT PSI GUIDES. DURING THE PROCEDURE, THE SURGEON NOTED THAT THE GUIDES DID NOT FIT WELL AND THAT THE SIZING WAS INCORRECT. FOR THIS REASON, AFTER THE SURGERY, HE REQUESTED A POST-CASE REVIEW, AND THE SALES REPRESENTATIVE (WHO WAS NOT PRESENT DURING THE SURGERY) DISCOVERED THAT THE WRONG GUIDES HAD BEEN USED. IN THE AUSTRALIAN WAREHOUSE, THE ONLY AVAILABLE GUIDES WITH MATCHING LETTERS OF CASE CODE WERE THE INCORRECT ONES. HOWEVER, NEITHER THE PATIENT'S DATE OF BIRTH NOR THE LOT NUMBER WAS CHECKED. ADDITIONALLY, SINCE THE PSIS WERE EXPIRED, THE WAREHOUSE WAS UNABLE TO SCAN THEM INTO THE SYSTEM. THE WAREHOUSE THEN INFORMED THE SALES REPRESENTATIVE ABOUT THE EXPIRED PSIS, WHO IN TURN NOTIFIED THE SURGEON. DESPITE KNOWING THAT THE GUIDES WERE EXPIRED, THE SURGEON APPROVED THEIR USE FOR THE SURGERY.
Patient problems: Insufficient Information
MAUDE report 21718981 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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