Profemur PLS0S416Recalls & reported problems

Microport Orthopedics Inc. · PROFEMUR RENAISSANCE STEM STANDARD SZ 16 · Class 3 · 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 M684PLS0S4161), received between Jul 15, 2021 and Oct 31, 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

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

Most reported problems

Device problems

Corroded1
Insufficient Device Problem Information1

Patient problems

Insufficient Information1
Pain1

Recent adverse event reports

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

InjuryOct 31, 2024Corroded; Corroded
ALLEGEDLY, POSSIBLE REVISION DUE TO PAIN AND CORROSION.
Patient problems: Pain
MAUDE report 20578436 ↗
InjuryJul 15, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, PATIENT WAS REVISED DO TO UNKNOWN REASONS, AFTER A LEFT HIP ARTHROPLASTY.
Patient problems: Insufficient Information
MAUDE report 12175228 ↗

Device details

UDI-DI	`M684PLS0S4161`
Brand	Profemur
Model	PLS0S416
Company	Microport Orthopedics Inc.
Product code	MRA · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
Class	Class 3
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.

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All Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented devices →

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