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INSTRUMENT 6541-5-705Recalls & reported problems

Howmedica Osteonics Corp. · MIS 4:1 CUTTING BLOCK TRIATHLON MIS INSTRUMENTS · Class 2

All models of INSTRUMENT (131)

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 07613327242171), received between Jul 25, 2018 and Jul 25, 2018 — classified as 1 malfunction.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Break1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionJul 25, 2018Break; Break

    PRIMARY PROCEDURE, RIGHT KNEE. IT WAS REPORTED THAT THE WELD BROKE ON THE POSTERIOR CAPTURE OF THE CUTTING BLOCK. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE DEVICE. ALL PIECES WERE REMOVED FROM THE PATIENT WITH NO SURGICAL DELAY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7718040 ↗

Other PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER devices

All PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page