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PROFEMUR® PRTL0023Recalls & reported problems

Microport Orthopedics Inc. · PROFEMUR® TL STEM SZ 3 · Class 2 · Implant

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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M684PRTL00231), received between Oct 1, 2019 and Apr 29, 2024 — classified as 2 injuries.

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

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 1 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Corroded2
  • Break1
  • Insufficient Device Problem Information1

Patient problems

  • Pain2
  • Loss of Range of Motion1
  • Metal Related Pathology1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 29, 2024Break; Corroded; Break; Corroded

    ALLEGEDLY, REVISION SURGERY WAS NECESSARY BECAUSE THE DEVICE FAILED DUE TO CORROSION AT THE HEAD-NECK JUNCTION AND NECK-STEM JUNCTION. THE PATIENT EXPERIENCE FRACTURE AT THE STEM AND MODULAR NECK JUNCTION, METALLOSIS, TISSUE REACTION, PSEUDOTUMOR, PAIN, LOSS OF MOBILITY AND CORROSION.

    Patient problems: Loss of Range of Motion; Metal Related Pathology; Pain

    MAUDE report 19203229 ↗
  • InjuryOct 1, 2019Corroded; Insufficient Device Problem Information; Corroded; Insufficient Device Problem Information

    (B)(4). PREVIOUSLY REPORTED PAIN IN R HIP INVESTIGATED VIA MRI, FOUND TO HAVE TWO LESIONS AT THE R HIP JOINT. (SEE ATTACHMENT).

    Patient problems: Pain

    MAUDE report 9142781 ↗

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

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

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