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
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 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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