Leg holder 100165A0Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046768001374), received between Dec 28, 2023 and Dec 28, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 28, 2023Use of Device Problem; Unintended Movement; Use of Device Problem; Unintended Movement

  ON 14TH DECEMBER 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES - 100165A0 - GOEPEL KNEE CRUTCH. AS IT WAS STATED, LEG HOLDER DID NOT HOLD THE POSITION AND AN UNINTENDED SLOW MOVEMENT OF THE ACCESSORY OCCURRED DURING POSITIONING OF THE PATIENT FOR THE PROCEDURE (SECTION). THE ACCESSORY WAS IMMEDIATELY EXCHANGED AND THE OPERATION WAS CONTINUED. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE UNINTENDED SLOW MOVEMENT OF THE ACCESSORY LEADING TO A CHANGE IN THE PATIENT'S POSITION, WAS TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18408105 ↗
• MalfunctionDec 28, 2023Use of Device Problem; Unintended Movement; Use of Device Problem; Unintended Movement

  ON 14TH DECEMBER 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES - 100165A0 - GOEPEL KNEE CRUTCH. AS IT WAS STATED, LEG HOLDER DID NOT HOLD THE POSITION AND AN UNINTENDED SLOW MOVEMENT OF THE ACCESSORY OCCURRED DURING POSITIONING OF THE PATIENT FOR THE PROCEDURE (SECTION). THE ACCESSORY WAS IMMEDIATELY EXCHANGED AND THE OPERATION WAS CONTINUED. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE UNINTENDED SLOW MOVEMENT OF THE ACCESSORY LEADING TO A CHANGE IN THE PATIENT'S POSITION, WAS TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18408037 ↗