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NA 160245Recalls & reported problems

Mako Surgical Corp. · FEMORAL ARRAY EXTENDED POST · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00848486003142), received between Jul 3, 2018 and Feb 18, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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

  • Break1
  • Detachment of Device or Device Component1
  • Fracture1
  • Material Integrity Problem1

Patient problems

  • No Known Impact Or Consequence To Patient2

Recent adverse event reports

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

  • MalfunctionFeb 18, 2020Break; Fracture; Break; Fracture

    PIN OF END EFFECTOR ATTACHMENT BROKE. CASE TYPE: THA. SURGICAL DELAY : <= 15 MINUTES.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9722488 ↗
  • MalfunctionJul 3, 2018Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem

    DURING REDUCTION RESULTS SURGEON BROKE PRONG OFF DISTAL END OF FEMORAL ARRAY STEM. PRONG WAS LOCATED IN VARIABLE ANGLE SCREW. THA PROCEDURE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7658870 ↗

Other Orthopedic stereotaxic instrument devices

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