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PROFEMUR® PRTL0021Recalls & reported problems

Microport Orthopedics Inc. · PROFEMUR® TL STEM SZ 1 · Class 2 · Implant

Data updated Oct 13, 2026 from official FDA records · Editorial policy

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 M684PRTL00211), received between Oct 5, 2022 and Feb 12, 2024 — classified as 2 injuries.

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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 1 reportsMar 2024: 0 reportsApr 2024: 0 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

  • Corroded1
  • Insufficient Device Problem Information1
  • Material Frayed1

Patient problems

  • Pain2
  • Metal Related Pathology1
  • Nerve Damage1

Recent adverse event reports

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

  • InjuryFeb 12, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

    ALLEGEDLY, REVISION DONE DUE TO PAINFUL HIP. THEY TOOK OUT THE STEM, NECK, HEAD AND POLY. THEY REPLACE THE POLY. PRODUCTS NO REVISE: PRODUCT: DSBFGD52 DYNASTY® BF SHELL 52MM GROUP D, LOT: 1502022, QTY: 1.

    Patient problems: Pain

    MAUDE report 18687092 ↗
  • InjuryOct 5, 2022Corroded; Material Frayed; Corroded; Material Frayed

    ALLEGEDLY, ON (B)(6) 2010 PATIENT HAD A WRIGHT MEDICAL ARTIFICIAL HIP IMPLANTED IN THE RIGHT SIDE OF HER BODY IN A PROCEDURE KNOWN AS A TOTAL HIP ARTHROPLASTY (THA). PATIENT'S ORTHOPEDIC SURGEON IN THE YEAR 2021, INFORMED PATIENT THAT IN HIS MEDICAL JUDGMENT IT WAS ADVISABLE TO UNDERGO A RIGHT HIP REVISION SURGERY TO REMOVE THE PROFEMUR HIP SYSTEM INCLUDING THE PROFEMUR PLUS COCR MODULAR NECK AND THE PROFEMUR TL FEMORAL STEM AND REPLACE IT WITH A HIP STEM SYSTEM OF A DIFFERENT MEDICAL DEVICE MANUFACTURER. ON (B)(6) 2021 PATIENT HAD A REVISION SURGERY PERFORMED ON HER RIGHT HIP. DUE TO MICROMOTION AND FRETTING CORROSION OF THE OBLONG TAPER OF THE PROFEMU PLUS COCR MODULAR NECK WHERE IT SEATED IN THE POCKET OF THE STEM, THE PROFEMUR PLUS COCR MODULAR NECK IMPLANTED IN PATIENT'S RIGHT HIP CORRODED CAUSING PHYSICAL INJURY TO PATIENT. PATIENT SUSTAINED INJURIES AND DAMAGES INCLUDING BUT NOT LIMITED TO PAIN, SUFFERING DISABILITY, AND PHYSICAL IMPAIRMENT. IT IS STATED THAT PATIENT'S PROFEMUR PLUS COCR MODULAR NECK SUFFERED MICROMOTION, FRETTING CORROSION, GALVANIC CORROSION, AND FRACTURE. IT IS ALSO STATED THAT PATIENT SUFFERED SERIOUS AND PERMANENT PHYSICAL INJURIES TO BONE, MUSCLE, TEND

    Patient problems: Metal Related Pathology; Nerve Damage; Pain

    MAUDE report 15544764 ↗

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

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Sources and updates

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