HOFFMANN 4933-1-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613252507796), received between Oct 3, 2019 and May 21, 2024 — 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.

• InjuryMay 21, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THERE WERE 3 WIRE BREAKAGES. AFTER CONCLUSION OF THE INVESTIGATION, IT WAS NOTED THAT THERE WAS A CLEAR INDICATION THAT THE WIRE BOLT WASN¿T TIGHTENED ENOUGH.

  Patient problems: Failure of Implant; Implant Pain; Nonunion/Delayed-union Bone Fracture

  MAUDE report 19367323 ↗
• MalfunctionAug 4, 2023Break; Fracture; Off-Label Use; Break; Fracture; Off-Label Use

  NO EVENT TO REPORT AS OF YET, AWAITING FURTHER INFORMATION. UPDATE 11 JUL 2023:- "WIRE BREAKAGE".

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17461813 ↗
• MalfunctionAug 4, 2023Break; Fracture; Off-Label Use; Break; Fracture; Off-Label Use

  NO EVENT TO REPORT AS OF YET, AWAITING FURTHER INFORMATION. UPDATE 11 JUL 2023:- "WIRE BREAKAGE".

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17461568 ↗
• 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 13424190 ↗
• 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 13423873 ↗
• 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 9156818 ↗
• InjuryOct 3, 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 9153695 ↗