HOFFMANN 4933-1-010Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613252610304), received between Apr 30, 2018 and Aug 31, 2023 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2023Break; Fracture; Device Difficult to Setup or Prepare; Off-Label Use; Break; Fracture; Device Difficult to Setup or Prepare; Off-Label Use

  NO EVENT TO REPORT AS OF YET, AWAITING FURTHER INFORMATION. UPDATE:- "WIRE BREAKAGE".

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17666981 ↗
• MalfunctionAug 31, 2023Break; Fracture; Off-Label Use; Break; Fracture; Off-Label Use

  NO EVENT TO REPORT AS OF YET, AWAITING FURTHER INFORMATION. UPDATE:- "WIRE BREAKAGE"

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17666978 ↗
• InjuryFeb 2, 2022Break; Break

  THE FOLLOWING EVENT WAS REPORTED BY THE STRYKER REP: "THE HOFFMANN LRF FRAME WAS PUT ON THE PATIENT ON (B)(6) 2021 FOR AN ANKLE FUSION PROCEDURE TO PROTECT THE INTERNAL HARDWARE. PATIENT NOTIFIED THE SURGEON ON (B)(6) 2022 COMPLAINING OF A LOUD 'POP' OR A LOOSE 'CLICKING SOUND. FRAME WAS REMOVED ON THE FOLLOWING DAY (B)(6) 2022. EVERY WIRE BROKE AND NUTS LOOSENED UP. THE SURGEON MENTIONED THE PATIENT WAS NOT WALKING ON IT THROUGHOUT THE FEW WEEKS IT WAS ON."

  Patient problems: Failure of Implant

  MAUDE report 13424189 ↗
• InjuryFeb 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING EVENT WAS REPORTED BY THE STRYKER REP: "THE HOFFMANN LRF FRAME WAS PUT ON THE PATIENT ON (B)(6) 2021 FOR AN ANKLE FUSION PROCEDURE TO PROTECT THE INTERNAL HARDWARE. PATIENT NOTIFIED THE SURGEON ON (B)(6) 2022 COMPLAINING OF A LOUD 'POP' OR A LOOSE 'CLICKING SOUND. FRAME WAS REMOVED ON THE FOLLOWING DAY (B)(6) 2022. EVERY WIRE BROKE AND NUTS LOOSENED UP. THE SURGEON MENTIONED THE PATIENT WAS NOT WALKING ON IT THROUGHOUT THE FEW WEEKS IT WAS ON."

  Patient problems: Failure of Implant

  MAUDE report 13419620 ↗
• InjuryOct 4, 2019Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED: "A COUPLE OF PROXIMAL PINS IN THE TIBIA IN AN LRF CASE WERE LOOSE." ALSO REPORTED: "THE REVISION WAS DONE DUE TO LOOSENING OF THE THIN WIRES. THE WIRES THAT APPEARED LOOSE WERE REPLACED BY HALF PINS, WHICH BECAME STABLE."

  Patient problems: No Code Available

  MAUDE report 9157093 ↗
• InjuryOct 4, 2019Loss of Osseointegration; Loosening of Implant Not Related to Bone-Ingrowth; Loss of Osseointegration

  AS REPORTED: "A COUPLE OF PROXIMAL PINS IN THE TIBIA IN AN LRF CASE WERE LOOSE." ALSO REPORTED: "THE REVISION WAS DONE DUE TO LOOSENING OF THE THIN WIRES. THE WIRES THAT APPEARED LOOSE WERE REPLACED BY HALF PINS, WHICH BECAME STABLE."

  Patient problems: Injury; No Code Available

  MAUDE report 9156719 ↗
• InjuryApr 30, 2018Break

  AS REPORTED: "THE PATIENT WAS WALKING WITH THE HOFFMANN LRF / HEXAPOD FRAME ON AND THE CLAMP BROKE". REP REPORTED THAT THE CLAMP WAS REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7472342 ↗