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PROFEMUR® PRGL0003Recalls & reported problems

Microport Orthopedics Inc. · PROFEMUR® GLADIATOR® PLASMA STEM SZ 3 · 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 M684PRGL00031), received between May 4, 2022 and May 4, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Corroded” (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

  • Corroded1

Patient problems

  • Metal Related Pathology1
  • Pain1

Recent adverse event reports

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

  • InjuryMay 4, 2022Corroded; Corroded

    ALLEGEDLY, THE PATIENT PRESENTED WITH PAIN AND ELEVATED COBALT AND CHROMIUM LEVELS. THE DEVICE FAILED DUE TO CORROSION AT THE NECK-STEM JUNCTION. AT REVISION SURGERY, IT WAS DISCOVERED THAT THE DEVICE FAILED DUE TO CORROSION OF THE OBLONG TAPER OF THE PROFEMUR COCR MODULAR NECK AND THE DOCTOR IDENTIFIED IN THE DIAGNOSES PREOPERATIVE OF THE REVISION SURGERY 'PAINFUL LEFT TOTAL HIP ARTHOPLASTY WITH METALLOSIS.

    Patient problems: Metal Related Pathology; Pain

    MAUDE report 14278092 ↗

Other Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented devices

All Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented devices →

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