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INSTRUMENT 1020-5203Recalls & reported problems

Howmedica Osteonics Corp. · ACCOLADE II BROACH · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327252613), received between Sep 10, 2018 and Sep 7, 2023 — classified as 2 malfunctions.

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
  • Fracture1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 7, 2023Fracture; Fracture

    THE "PEG" ON THE FEMORAL RASP IS BROKEN OFF.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17705590 ↗
  • MalfunctionSep 10, 2018Break; Break

    PRIMARY PROCEDURE, RIGHT HIP. IT WAS REPORTED THAT UPON IMPACTION OF THE ACCOLADE II BROACH, THE COLOR INDICATOR BROKE OFF IN THE PATIENT. PIECE WAS REMOVED, PATIENT WAS VISUALLY INSPECTED AND IRRIGATED WITH NO SURGICAL DELAY. PROCEDURE COMPLETED SUCCESSFULLY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7861727 ↗

Other Prosthesis, hip, semi-constrained, metal/polymer, uncemented devices

All Prosthesis, hip, semi-constrained, metal/polymer, uncemented devices →

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