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Trident 502-01-60GRecalls & 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 07613153073123), received between Oct 22, 2018 and Oct 22, 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

  • Ambulation or Postural Difficulties1
  • Inadequate Osseointegration1
  • Injury1
  • Joint Dislocation1
  • Pain1
  • Swelling1

Recent adverse event reports

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

  • InjuryOct 22, 2018Loss of Osseointegration; Loss of Osseointegration

    IT WAS REPORTED BY THE PATIENT AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY AFTER THE IMPLANTATION HE DEVELOPED PAIN AND SWELLING WHICH WORSENS AS TIME WENT BY. DURING THE NEXT TWO YEARS BESIDES THE PAIN AND SWELLING THE LEG STARTED TO THUMP WHEN HE WALKED AND SOMETIMES THE HIP WOULD LOCK UP AND COULD NOT MOVE. IT IS FURTHER ALLEGED THAT THE PATIENT WAS REVISED ON DECEMBER 18, 2017 AND DURING THE PROCEDURE THE SURGEON FOUND THAT THE BALL HAD DISINTEGRATED IN THE LEG AND FOUR HOURS WERE SPENT PICKING OUT SHARDS AND SPLINTERS THAT HAD EMBEDDED IN HIS LEG.UPDATE PER MEDICAL REVIEW: ¿ON (B)(6) 2017 HE HAD A LEFT HIP ASPIRATION UNDER LOCAL ANESTHESIA AND FLUOROSCOPIC CONTROL. TOE FLUID WAS SENT FOR GRAM STAIN, CULTURE AND CELL COUNT. LAB REPORT OF RESULTS OF (B)(6) 2017 LEFT HIP ASPIRATE RESULTS: "NO ORGANISMS SEEN" ON GRAM STAIN AND "NO GROWTH AT 3 DAYS" ON CULTURE. CELL COUNT FROM ASPIRATE IS NOT DIAGNOSTIC OF INFECTION.¿ ¿ON (B)(6) 2017 A REVISION LEFT TOTAL HIP ARTHROPLASTY (BOTH COMPONENTS) FOR A PRE­ AND POST-OPERATIVE DIAGNOSIS OF "LEFT HIP PAIN STATUS-POST THA, DISLOCATED LEFT HIP, LOOSENING OF HARDWARE". A BRIEF OPERATIVE REPORT DESCRIBES SPINAL ANESTHESIA AND A LATERAL APPR

    Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration; Injury; Joint Dislocation; Pain; Swelling

    MAUDE report 7992355 ↗

Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices

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