HOFFMANN 4934-8-180Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613252592020), received between Feb 15, 2024 and Feb 15, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Material Separation” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 15, 2024Material Separation; Material Separation

  AS REPORTED: "SURGERY TOOK PLACE SUCCESSFULLY ON (B)(6) 2023, PATIENT CAME FOR A CHECK-UP AND THE DEFECT WAS DISCOVERED. PATIENT IS CURRENTLY NOT ABLE TO PUT OPTIMAL WEIGHT ON THE LEG AND STEP ON IT DUE TO THE DAMAGE TO THE PRODUCT."

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant

  MAUDE report 18712747 ↗