Mako 180735-3Recalls & reported problems

Mako Surgical Corp. · Tibial Bearing Insert · 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 00848486016562), received between Aug 12, 2020 and Aug 12, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

Most reported problems

Device problems

Insufficient Device Problem Information1

Patient problems

Injury1
Unspecified Infection1

Recent adverse event reports

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

InjuryAug 12, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
DR. PERFORMED AN I&D AND INSERT SWAP ON THE RIGHT MEDIAL MAKO UNI DUE TO INFECTION.
Patient problems: Injury; Unspecified Infection
MAUDE report 10395852 ↗

Device details

UDI-DI	`00848486016562`
Brand	Mako
Model	180735-3
Company	Mako Surgical Corp.
Product code	HSX · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
Class	Class 2
FDA submission	K150307, K150410, K220930, K242831
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	Jun 18, 2026

Device type (GMDN): Unicondylar knee prosthesis

A sterile artificial substitute for the bearing surface of only one femoral condyle and corresponding tibial condyle of the knee (medial or lateral condyle) implanted during primary or revision knee replacement. It typically consists of femoral and tibial components and a knee insert which are made of metal or polyethylene (PE); fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement. The device is indicated in unicompartmental disease and/or damage (e.g., from arthritis) to the bearing surfaces of the knee.

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All PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER devices →

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