Skip to content

NA 112210Recalls & reported problems

Mako Surgical Corp. · KNEE FEMORAL ARRAY · Class 2

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 00848486002909), received between Nov 2, 2018 and Nov 2, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical 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

  • Mechanical Problem1
  • Non Reproducible Results1

Patient problems

  • 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.

  • MalfunctionNov 2, 2018Mechanical Problem; Non Reproducible Results; Mechanical Problem; Non Reproducible Results

    FEMORAL ARRAY FLICKERED IN AND OUT THROUGHOUT CASE; VIZADISCS WERE SWAPPED MULTIPLE TIMES; BURR WOULD NOT START. ONCE ARRAY WAS SWAPPED, CASE CONTINUED. SURGICAL DELAY 16-30 MINUTES. CASE TYPE: PKA.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8034415 ↗

Other Orthopedic stereotaxic instrument devices

All Orthopedic stereotaxic instrument devices →

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