Skip to content

Mako 180734-2Recalls & 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 00848486016500), received between Jan 27, 2021 and Jan 27, 2021 — classified as 1 injury.

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

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Pain1

Recent adverse event reports

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

  • InjuryJan 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE PATIENT HAD BILATERAL TKA DONE ON (B)(6) 2018. PATIENT HAS BEEN EXPERIENCING PAIN ON BOTH KNEES SINCE HER SURGERY. PATIENT HAS HAD PHYSICAL THERAPY FOR ABOUT 6 WEEKS. THE PATIENT STATED HER PAIN HAS BEEN CONSISTENT AND HAS NEVER BEEN THE SAME SINCE HER SURGERY. PATIENT HAD LEFT KNEE X-RAY DONE ON (B)(6) 2020 AND AS PER HER SURGEON THE RESULTS SHOW HER LEFT KNEE IS NARROWING. SHE WOULD LIKE TO KNOW IF HER IMPLANTS ARE PART OF RECALL AND IS SEEKING COMPENSATION. THIS PI IS FOR THE RIGHT KNEE

    Patient problems: Pain

    MAUDE report 11236856 ↗

Other PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER devices

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

Sources and updates

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