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Trident 500-11-50DRecalls & reported problems

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

All models of Trident (160)

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

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540431851), received between Nov 30, 2017 and Nov 27, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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

  • Inadequacy of Device Shape and/or Size1
  • Insufficient Device Problem Information1

Patient problems

  • Bone Fracture(s)1
  • Injury1
  • 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.

  • MalfunctionNov 27, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

    SURGEON QUESTIONING WHETHER IMPLANT WAS SIZED CORRECTLY ¿ TRIDENT HEMISPHERICAL CLUSTER SHELL SIZE 50D (500-11-50D) SURGEON FELT SHELL SEEMED TO BE SIZED INCORRECTLY AND WAS ACTUALLY A SIZE 48MM. BOX, STICKERS AND IMPLANTS ALL STATED IT WAS 500-11-50D HOWEVER SIZE IN COMPARISON TO WINDOW TRIAL AND OTHER SHELLS SEEMED SMALLER THAN USUAL. PRIMARY SURGERY. OPTED TO USE A CEMENTED RIM-FIT CUP WITH ALUMINA HEAD.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8105559 ↗
  • InjuryNov 30, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

    WHILE IMPLANTING SOLID BACK TRIDENT HEMISPHERICAL CUP, THE PATIENT'S ACETABULUM FRACTURED. REAMING OF THE ACETABULAR WAS CARRIED OUT TO UNDER 1MM PRIOR TO INSERTION AS PER OP TECHNIQUE. THE SOLID BACK CUP WAS REMOVED AND A CLUSTER CUP REPLACED IT.

    Patient problems: Bone Fracture(s); Injury

    MAUDE report 7071877 ↗

Other Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate devices

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Sources and updates

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