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Mako 180733-2Recalls & reported problems

Mako Surgical Corp. · Tibial Bearing Insert · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00848486016456), received between Jun 2, 2017 and Jun 2, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fitting Problem” (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

  • Fitting Problem1
  • Material Deformation1

Patient problems

  • No Consequences Or Impact To Patient1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionJun 2, 2017Fitting Problem; Material Deformation

    POLY FAILED TO FIT INTO BASEPLATE SO WE HAD TO OPEN A NEW ONE AND THE NEW ONE WENT RIGHT IN. IT SEEMS TO BE JUST MISSHAPED.

    Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

    MAUDE report 6607590 ↗

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.