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Trident 542-11-42BRecalls & reported problems

Howmedica Osteonics Corp. · Cluster Acetabular Shell · Class 2 · Implant

Adverse event reports
4
Deaths reported
0
Injuries reported
4
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540240446), received between Nov 3, 2020 and Jul 6, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (2 reports).

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

  • Osseointegration Problem2
  • Fracture1
  • Loosening of Implant Not Related to Bone-Ingrowth1
  • Loss of Osseointegration1
  • Malposition of Device1

Patient problems

  • Bone Fracture(s)2
  • Inadequate Osseointegration2
  • Insufficient Information1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 6, 2021Osseointegration Problem; Osseointegration Problem

    THE FOLLOWING WAS REPORTED: LOOSENING. DATE OF SURGERY AND EVENT DATE ARE UNKNOWN. 4 YEARS AFTER THE PROCEDURE. DEVICE IS TRIDENT PSL, BUT SIZE IS UNKNOWN.

    Patient problems: Inadequate Osseointegration

    MAUDE report 12125638 ↗
  • InjuryJul 5, 2021Osseointegration Problem; Osseointegration Problem

    LOOSENING. NO INFECTION. NO REVISION IS PLANNED SO FAR. PRIMARY SURGERY DATE IS UNKNOWN.

    Patient problems: Insufficient Information

    MAUDE report 12116202 ↗
  • InjuryNov 3, 2020Fracture; Fracture

    INTRAOPERATIVE ACETABULAR FRACTURE. EVENT WAS NOTED IN EVENT DESCRIPTION OF (B)(4). UPDATE 16 OCTOBER 2020: INTERVENTION FOR THE FRACTURE WAS UNCLEAR, BUT SCREWS WERE PLACED IN THE CUP.

    Patient problems: Bone Fracture(s)

    MAUDE report 10780159 ↗
  • InjuryNov 3, 2020Loss of Osseointegration; Malposition of Device; Loosening of Implant Not Related to Bone-Ingrowth; Loss of Osseointegration; Malposition of Device; Loosening of Implant Not Related to Bone-Ingrowth

    42MM TRIDENT CUP WAS REVISED FOR LOOSENING. INITIAL SURGERY WAS DONE ON (B)(6) 2016 - SURGEON REPORTED AN INTRA OPERATIVE ACETABULAR FRACTURE, WHICH DID NOT HEAL AND LED TO CUP LOOSENING.

    Patient problems: Bone Fracture(s); Inadequate Osseointegration

    MAUDE report 10779484 ↗

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.