RESTORIS 186004-09Recalls & reported problems

Mako Surgical Corp. · Tapered Femoral Stem, Ext Offset Neck, 12/14 Taper · Class 2 · Implant

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 00848486008123), received between Apr 25, 2024 and Apr 25, 2024 — classified as 1 injury.

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

Patient problems

Metal Related Pathology1
Pain1

Recent adverse event reports

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

InjuryApr 25, 2024Corroded; Corroded
IT WAS REPORTED BY AN ATTORNEY THAT PLAINTIFF UNDERWENT A REVISION OF A HIP DUE TO ADVERSE LOCAL TISSUE REACTION. THIS PI IS FOR THE PATIENT'S RIGHT HIP REVISION.
Patient problems: Metal Related Pathology; Pain
MAUDE report 19179140 ↗

Device details

UDI-DI	`00848486008123`
Brand	RESTORIS
Model	186004-09
Company	Mako Surgical Corp.
Product code	OQH · Hip, semi-constrained, cemented, metal/polymer + additive, cemented
Class	Class 2
FDA submission	K112802
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 femoral stem prosthesis

A sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device 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 is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel].

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