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Mako 180736-1Recalls & reported problems

Mako Surgical Corp. · Tibial Bearing Insert · Class 2 · 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 00848486016593), received between May 31, 2017 and Jul 30, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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 Information2

Patient problems

  • Unspecified Infection2
  • Injury1

Recent adverse event reports

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

  • InjuryJul 30, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

    DR...PERFORMED AN I&D WITH TIBIAL INSERT EXCHANGE DUE TO POSSIBLE INFECTION OF A LEFT MEDIAL UNI.

    Patient problems: Unspecified Infection

    MAUDE report 12252144 ↗
  • InjuryMay 31, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

    SALES REP REPORTED AN PRIMARY REVISION SURGERY DUE TO INFECTION. REPLACED POLY INSERT WITH NEW SIZE 6-8MM POLY.

    Patient problems: Injury; Unspecified Infection

    MAUDE report 6600468 ↗

Other PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, UNICOMPARTMENTAL/UNICONDYLAR, UNCEMENTED, POROUS-COATED, METAL/POLYMER devices

All PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, UNICOMPARTMENTAL/UNICONDYLAR, UNCEMENTED, POROUS-COATED, METAL/POLYMER devices →

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