Skip to content

Mako 180738-1Recalls & reported problems

Mako Surgical Corp. · Tibial Bearing Insert · 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 00848486016692), received between Oct 25, 2021 and Oct 25, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Degraded” (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.

Most reported problems

Device problems

  • Degraded1
  • Insufficient Device Problem Information1

Patient problems

  • Bacterial Infection1
  • Insufficient Information1

Recent adverse event reports

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

  • InjuryOct 25, 2021Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

    IT WAS REPORTED THE PATIENT'S LEFT MEDIAL PKA WAS REVISED. AN 8X8 POLY WAS EXCHANGED FOR ANOTHER 8X8 POLY. INTRA-OPERATIVELY, APPRECIABLE WEAR WAS NOTED ON THE INSERT. REP WOULD LIKE TO HAVE THE INSERT INVESTIGATED UPON RETURN AND CONFIRMED NO FURTHER INFORMATION WILL BE RELEASED.

    Patient problems: Bacterial Infection; Insufficient Information

    MAUDE report 12690137 ↗

Other Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive devices

All Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page