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INSTRUMENT I-H1551HF00Recalls & reported problems

Howmedica Osteonics Corp. · SPECIALTY ACCOLADE OFFSET STEM INSERTER · Class 2

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 07613327297539), received between Jan 9, 2019 and Jan 9, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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

  • Fracture1

Patient problems

  • Foreign Body In Patient1

Recent adverse event reports

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

  • MalfunctionJan 9, 2019Fracture; Fracture

    ON (B)(6) 2018 SURGICAL PROCEDURE INITIALLY PERFORMED. IT WAS CONFIRMED NO ISSUE AFTER PROCEDURE BASED ON X RAY. ON (B)(6) 2018 DURING FOLLOW UP, IT WAS CONFIRMED A PIECE OF METAL, SO IT WAS CONFIRMED THE INSTRUMENTS BROKEN AND REMAIN IN PATIENT INITIAL PROCEDURE.

    Patient problems: Foreign Body In Patient

    MAUDE report 8232196 ↗

Other Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish devices

All Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish devices →

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