Profemur PHA00234Recalls & reported problems

Microport Orthopedics Inc. · PROFEMUR Z SIZE 2 STEM · Class 2 · Implant

All models of PROFEMUR (116)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 3
Deaths reported: 0
Injuries reported: 3
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M684PHA002341), received between Feb 20, 2020 and Oct 3, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Break1
Corroded1
Insufficient Device Problem Information1
Material Disintegration1

Patient problems

Pain2
Failure of Implant1
Metal Related Pathology1
Osteolysis1
Reaction1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

InjuryOct 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, PATIENT UNDERWENT REVISION SURGERY ON RIGHT HIP DUE TO PAIN FROM UNDERLYING MECHANICAL ASSISTED CREVICE CORROSION FROM MODULAR, COBALT CHROME RIGHT HIP REPLACEMENT WITH AN ELEVATED COBALT LEVELS AND EVIDENCE OF PSEUDOTUMOR ON MRI AND METALLOSIS. NON MPO PRODUCTS: ZIMMER BIOMET RB 50 MM ACETABULAR COMPONENT, 50/36 POLYLINER, 25 MM ACETABULAR SCREW.
Patient problems: Metal Related Pathology; Pain
MAUDE report 20360482 ↗
InjuryAug 3, 2022Break; Break
ALLEGEDLY, FOUR YEARS AFTER THE LEFT THA, RADIOGRAPHS SHOW STEM FRACTURE IN DISTAL PORTION, REVISION HAS BEEN SCHEDULED (B)(6) 2022. THE DISTAL PORTION WILL BE LEFT AS IT IS, AND A CEMENTED STEM FROM ANOTHER COMPANY WILL BE INSERTED. (B)(4).
Patient problems: Failure of Implant
MAUDE report 15160554 ↗
InjuryFeb 20, 2020Corroded; Material Disintegration; Corroded; Material Disintegration
ALLEGEDLY, PATIENT PRESENTED ELEVATED COBALT ION LEVELS AND PAIN. THE DEVICE FAILED DUE TO CORROSION AT THE NECK-STEM JUNCTION OF THE DEVICE, CORROSION ON THE OBLONG TAPER WHERE THE NECK WAS SEATED IN THE POCKET OF THE PROFEMUR TITANIUM STEM, WHICH CAUSED ADDUCTOR DAMAGE, SOFT TISSUE REACTION AND PSEUDOTUMOR REACTION. DURING THE REVISION THE SURGEON REMOVED THE FAILED COMPONENTS OF THE PROFEMUR TOTAL HIP SYSTEM.
Patient problems: Osteolysis; Pain; Reaction
MAUDE report 9733090 ↗

Device details

UDI-DI	`M684PHA002341`
Brand	Profemur
Model	PHA00234
Company	Microport Orthopedics Inc.
Product code	LPH · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Mar 29, 2018

Device type (GMDN): Press-fit hip femur prosthesis, modular

A sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck. The device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined, and is contoured to enable fixation by pressing the distal end into the cortex of the remaining natural femur to achieve a mechanical interlock without the use of bone cement. The device may be made of metal and/or ceramic materials; supplemental fixation devices for implantation (e.g., screws and bolts) may be included.

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

PINNACLE 1217-25-500
Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
735 reports
NA 1365-52-000
Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
683 reports
APEX 1246-03-000
Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
3 deaths613 reports
PINNACLE 1217-20-500
Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
2 deaths590 reports
PINNACLE 1217-30-500
Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
1 death484 reports
NA 1365-53-000
Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
404 reports
PINNACLE ALTRX 1221-36-054
Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
388 reports
PINNACLE ALTRX 1221-32-050
Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
386 reports

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

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 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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