H-MAX S Lateralizing Uncemented StemRecalls & reported problems

Limacorporate SPA · H-MAX S Lateralizing Uncemented stems (Ti6Al4V + HA) n.8 · Class 2 · Implant

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

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033390061506), received between Jan 7, 2025 and Jan 7, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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

Loosening of Implant Not Related to Bone-Ingrowth1
Patient Device Interaction Problem1

Patient problems

Inadequate Osseointegration1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryJan 7, 2025Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth; Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth
HIP REVISION SURGERY PERFORMED ON (B)(6) 2024, DUE TO IMPLANT LOOSENING. ACCORDING TO THE RECEIVED INFORMATION, BASED ON THE X-RAYS THE H-MAX S LATERALIZED FEMORAL STEM #8 (PRODUCT CODE 4251.20.080, LOT #1304218 - STER. 1400114) WAS UNDERSIZED AND HAD SUBSIDED. IT WAS REPORTED IT IS NOT KNOWN HOW LONG THE STEM HAD BEEN SUBSIDING, AND THAT NO SPECIFIC EVENT FOR THE SUBSIDENCE WAS DETERMINED. THE FOLLOWING COMPONENTS WERE REMOVED: · H-MAX S LATERALIZED FEMORAL STEM #8 (PRODUCT CODE 4251.20.080, LOT #1304218 - STER. 1400114) · FEMORAL MODULAR HEAD - S Ø36MM (PRODUCT CODE 5010.09.361, LOT #1610104 - STER. 1600216) · DELTA NEUTRAL LINER ØINT 36MM #L (PRODUCT CODE 5885.51.260, LOT #1618032 - STER. 1700028) IT WAS REPORTED THAT DURING SURGERY THE STEM WAS FOUND TO NOT BE LOOSE AND CONSEQUENTLY IT TOOK SOME TIME TO REMOVE THE BONE WHICH SEEMED TO HOLD THE STEM FIRMLY IN THE FEMUR. THE SURGEON RESPONSIBLE FOR THE REVISION SURGERY IS DIFFERENT FROM THE SURGEON RESPONSIBLE FOR THE PRIMARY IMPLANT. PATIENT IS A FEMALE, 73 YEARS OLD. NO OTHER CLINICAL INFORMATION WAS AVAILABLE. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2017. EVENT HAPPENED IN AUSTRALIA.
Patient problems: Inadequate Osseointegration
MAUDE report 21091078 ↗

Device details

UDI-DI	`08033390061506`
Brand	H-MAX S Lateralizing
Model	Uncemented Stem
Catalog no.	4251.20.080
Company	Limacorporate SPA
Product code	MEH · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
Class	Class 2
FDA submission	K112091, K150855, K160011
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): Coated femoral stem prosthesis, modular

A sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is composed of two or more separate segments designed to be joined, typically made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel], and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.

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All Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate 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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