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Trident 502-01-64HRecalls & reported problems

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

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 07613153073147), received between Dec 12, 2018 and Dec 12, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Loss of Osseointegration” (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

  • Loss of Osseointegration1

Patient problems

  • Injury1
  • Osteolysis1

Recent adverse event reports

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

  • InjuryDec 12, 2018Loss of Osseointegration; Loss of Osseointegration

    AS REPORTED: "LOOSE COMPONENTS WITH SEVERE OSTEOLYSIS. REPLACED WITH 64MM TRITANIUM MULTIHOLE CUP WITH 4 SCREWS 2X20, 2X25, 36MM E 0° LINER, RESTORATION MODULAR 21 X 155 STEM X 20 BODY, 36 +5 BIOLOX HEAD. ROUTINE REVISION THA". THE SHELL AND STEM WERE REPORTED LOOSE. NOTHING REGARDING THE SCREWS WAS REPORTED. IT WAS CONFIRMED THAT THIS WAS A REVISION OF THE PRIMARY, CLARIFIED LOT NUMBER ON STEM.

    Patient problems: Injury; Osteolysis

    MAUDE report 8157519 ↗

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.