Masterloc Femoral Stems 01.39.004Recalls & reported problems

Medacta International SA · Masterloc Cementless Ti Coated STD Stem # 4 · Class 2 · Implant

All models of Masterloc Femoral Stems (21)

Data updated Oct 18, 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 07630030885532), received between May 29, 2018 and Feb 13, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (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 18, 2026.

Most reported problems

Device problems

Osseointegration Problem1
Positioning Problem1

Patient problems

Joint Disorder1
Pain1

Recent adverse event reports

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

InjuryFeb 13, 2020Osseointegration Problem; Osseointegration Problem
REVISION SURGERY DUE TO PAIN AND LEG LENGTH DISCREPANCY 2 MONTHS AFTER PRIMARY, THE STEM WAS SUBSIDED. THE STEM AND THE HEAD HAVE BEEN REVISED.
Patient problems: Pain
MAUDE report 9705042 ↗
InjuryMay 29, 2018Positioning Problem
THE SAME DAY OF THE SURGERY THE PATIENT WAS REOPENED FOR STEM ROTATION INSIDE THE FEMORAL CANAL. STEM AND HEAD SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Disorder
MAUDE report 7549086 ↗

Device details

UDI-DI	`07630030885532`
Brand	Masterloc Femoral Stems
Model	01.39.004
Company	Medacta International SA
Product code	LZY · Prosthesis, Hip, Hemi-, Femoral, Metal Ball
Class	Class 2
FDA submission	K151531
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 6, 2018

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

A sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck. The device is one-piece 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, Hemi-, Femoral, Metal Ball devices

NA 1363-10-000
Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal ball
117 reports
NA 1363-08-000
Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal ball
66 reports
NA 1363-12-000
Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal ball
44 reports
NA 1363-46-000
Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal ball
39 reports
NA 1363-47-000
Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal ball
34 reports
NA 1363-45-000
Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal ball
31 reports
NA 1363-44-000
Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal ball
25 reports
NA 1363-49-000
Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal ball
23 reports

All Prosthesis, Hip, Hemi-, Femoral, Metal Ball 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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