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ADVANCE® K0031103Recalls & reported problems

Microport Orthopedics Inc. · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M684K00311031), received between Nov 2, 2021 and Nov 2, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1

Patient problems

  • Device Embedded In Tissue or Plaque1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 2, 2021Break; Break

    ALLEGEDLY, DURING A EVOLUTION TOTAL KNEE PROCEDURE, WHILE DRILLING THE PATELLA 3 PEG BUTTON, DOCTOR NOTICED THERE WERE A COUPLE MISSING SPIKES FROM THE CLAMP. HE ALSO MADE THE ASSUMPTION THAT ONE OF THOSE SPIKES IS IN A PATIENTS KNEE CAP BUT HE DID NOT RECALL WHICH PATIENT AT THE TIME.

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 12738754 ↗

Other CLAMP devices

All CLAMP devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.