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NA 164206Recalls & reported problems

Mako Surgical Corp. · KNEE TENSIONER · Class 2

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00848486029784), received between Aug 21, 2018 and Sep 9, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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

  • Break2
  • Device Difficult to Setup or Prepare1
  • Fracture1

Patient problems

  • No Consequences Or Impact To Patient3
  • No Patient Involvement1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 9, 2019Fracture; Device Difficult to Setup or Prepare; Fracture; Device Difficult to Setup or Prepare

    PIN HAS FALLEN OUT ON THE TENSION ER. CASE TYPE: TKA. UPDATE: "WAS THE PATIENT UNDER ANESTHESIA? NO".

    Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

    MAUDE report 8975565 ↗
  • MalfunctionDec 5, 2018Break; Break

    KNEE TENSIONER TOOL BROKE DURING LIGAMENT BALANCING. CASE TYPE: TKA.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8133949 ↗
  • MalfunctionAug 21, 2018Break; Break

    GAP BALANCER BROKE DURING GAP BALANCING. CASE TYPE: TKA.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7803940 ↗

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