HOFFMANN 4934-6-180Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613252611509), received between May 1, 2018 and Dec 5, 2020 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment Of Device Component” (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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IN REPORTING THE FACT THAT A HOFFMANN LRF FOOT ARCH CAME APART WHERE THE CARBON FIBER MEETS THE METAL ON (B)(6) 2020, THE SURGEON REPORTED THE SAME PROBLEM HAPPENED WITH THE SAME PATIENT ONE WEEK PREVIOUSLY.

  Patient problems: Failure of Implant

  MAUDE report 10953160 ↗
• InjuryDec 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, "IN REPORTING THE FACT THAT A HOFFMANN LRF FOOT ARCH CAME APART WHERE THE CARBON FIBER MEETS THE METAL ON (B)(6) 2020. THE SURGEON REPORTED, THE SAME PROBLEM HAPPENED WITH THE SAME PATIENT ONEWEEK PREVIOUSLY".

  Patient problems: Failure of Implant

  MAUDE report 10953142 ↗
• InjuryDec 19, 2018Break

  THIS PI IS FOR THE FIRST REVISION OF THE PATIENT'S FOOT ARCH. AS REPORTED: "PATIENT WAS LOW WEIGHT BEARING AND BROKE A FOOT ARCH. WE REPLACE[D] THE FOOT ARCH WITH NEW ONE..." REP INDICATED PATIENT FACTOR: DIABETIC.

  Patient problems: No Code Available

  MAUDE report 8182772 ↗
• InjuryDec 19, 2018Fracture; Device Slipped

  THIS PI IS FOR THE SECOND REVISION OF PATIENT'S FOOT ARCH, AND HEXAPOD STRUT ISSUE. AS REPORTED: "...WE REPLACE THAT FOOT ARCH WITH A NEW ONE AND HE[PATIENT] BREAKS THAT ONE THE FOLLOWING WEEK. BRING HIM BACK TO OFFICE AND REVISE. WHILE REVISING WE NOTICE THE PIN IN THE HEXAPOD STRUT WAS STARTING TO COME OUT". REP INDICATED PATIENT FACTOR: DIABETIC. REVISION, BROKEN FOOT ARCH, HEXAPOD STRUT MALFUNCTION

  Patient problems: No Code Available

  MAUDE report 8182768 ↗
• MalfunctionMay 1, 2018Detachment Of Device Component

  FOOT ARCH ON HLRF DISTAL TIBIAL FRAME HAS DETACHED CARBON RING FROM METAL ATTACHMENT POST. PATIENT AT PRESENT HAS FOOT ARCH STILL ATTACHED AS SURGEON HAS FORCED IT BACK TOGETHER. IT IS ANTICIPATED THAT PATIENT WILL HAVE TO HAVE THIS REVISED.

  Patient problems: No Code Available

  MAUDE report 7475069 ↗
• InjuryMay 1, 2018Detachment Of Device Component

  FOOT ARCH ON HLRF HAS DETATCHED FROM FRAME 8+ WEEKS POST INITIAL SURGERY. PATIENT HAS UNDERWENT SURGERY TO REVISE FRAME. PATIENT HAS HAD TO UNDERGO SUBSEQUENT SURGERY FOR THIS ISSUE PLUS REPLACEMENT OF A FEW OTHER COMPONENTS.

  Patient problems: No Code Available

  MAUDE report 7475053 ↗