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Trident 540-11-54FRecalls & reported problems

Howmedica Osteonics Corp. · Solid Back Acetabular Shell · Class 2 · Implant

All models of Trident (160)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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 04546540237842), received between Jul 11, 2018 and Jul 11, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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

  • Insufficient Device Problem Information1

Patient problems

  • Injury1

Recent adverse event reports

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

  • InjuryJul 11, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

    THIS PI IS FOR THE SECOND REVISION ON (B)(6) 2018 IN WHICH A SHELL (IMPLANTED (B)(6) 2011), LINER, AND HEAD (BOTH IMPLANTED (B)(6) 2012) WERE REVISED. POSTOPERATIVE DIAGNOSIS: PATIENT HAD AN INDEX SURGERY WITH A MODULAR ABG PERFORMED IN (B)(6) 2011, WHICH NEEDED REVISION DUE TO STEM-NECK CORROSION (PERFORMED ON (B)(6) 2012). AT THAT TIME ALL COMPONENTS WERE EXCHANGED EXCEPT THE SHELL. THE PATIENT PRESENTED WITH HIP INSTABILITY, AND NOW [(B)(6) 2018] DOCTOR PERFORMED AN OFF-LABEL REVISION WITH CONSTRAINED COMPONENTS. ALL COMPONENTS EXCEPT FOR THE REVISED STEM (A NON-MODULAR ABG II) WERE EXCHANGED AT THIS TIME.

    Patient problems: Injury

    MAUDE report 7678449 ↗

Other PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices

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Sources and updates

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