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HANA LEG SPAR LIFT ASSIST, LEFT 6875-3900Recalls & reported problems

Mizuho Orthopedic Systems, Inc. · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842430109010), received between Apr 23, 2020 and Jun 9, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Device Dislodged or Dislocated1
  • Positioning Problem1
  • Unintended Movement1

Patient problems

  • Injury1
  • No Code Available1
  • Perforation1

Recent adverse event reports

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

  • InjuryJun 9, 2020Device Dislodged or Dislocated; Unintended Movement; Device Dislodged or Dislocated; Unintended Movement

    IT WAS REPORTED TABLE WOULD NOT HOLD ITS POSITION, THEREFORE THE PATIENT WAS NOT POSITIONED CORRECTLY. THIS CAUSE REAMING THOUGH THE SIDE WALL OF THE FEMUR.

    Patient problems: Injury; Perforation

    MAUDE report 10134561 ↗
  • MalfunctionApr 23, 2020Positioning Problem

    THE HANA TABLE WOULD NOT HOLD ITS POSITION, THEREFORE THE PATIENT WAS NOT POSITIONED CORRECTLY. THIS CAUSED REAMING THROUGH THE SIDE WALL OF THE FEMUR. THE GENTLEMAN WHO WAS CALLED TO SERVICE THE BED SEEMED TO THINK THAT THE CAUSTIC NATURE OF THE CLEANER MAY HAVE CONTRIBUTED TO THE BREAKDOWN OF THE INNER MECHANISMS USED TO LOCK THE ARTICULATING PIECES IN PLACE. MANUFACTURER RESPONSE FOR TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED, HANA LEG SPAR LIFT ASSIST, LEFT (PER SITE REPORTER). SEE ORIGINAL DESCRIPTION.

    Patient problems: No Code Available

    MAUDE report 9990118 ↗

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Sources and updates

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