Leg holder 100380A0Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04046768142138), received between Nov 22, 2023 and Mar 28, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Component Missing” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 28, 2025Fracture; Unintended Movement; Fracture; Unintended Movement

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES - 100380A0 - LEG HOLDER USED WITH 720001B0 - MEERA EU WITHOUT AUTO DRIVE. DURING A LEG SURGICAL PROCEDURE, AN ISSUE OCCURRED WHEN THE LOCKING MECHANISM OF THE LEFT LEG HOLDER FAILED. THE FIXING BOLT FRACTURED, CAUSING THE PATIENT¿S SECURED LEG TO SUDDENLY DROP. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE FAST UNINTENDED MOVEMENT RESULTING IN THE CHANGE OF THE PATIENT'S POSITION, WAS TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21717330 ↗
• MalfunctionMar 6, 2024Component Missing; Detachment of Device or Device Component; Component Missing; Detachment of Device or Device Component

  ON 21ST FEBRUARY 2024, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES - 100380A0 - LEG HOLDER. AS IT WAS STATED, ALL FOUR PAN HEAD SCREWS ON THE SHOE JOINT TAPING OF THE LEG HOLDER WERE FOUND TO BE MISSING ON THE RIGHT SIDE. BOOT SECURING PLATE HAD BECOME DETACHED FROM ASSEMBLY WHEN THE STAFF PICKED THE DEVICE TO MOVE IT. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE USE OF A LEG HOLDER WITH MISSING SCREWS DURING SURGERY WHICH COULD RESULT IN UNINTENDED CHANGE IN PATIENT POSITION OR PATIENT'S FALL, WAS TO OCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18844184 ↗
• MalfunctionMar 6, 2024Component Missing; Detachment of Device or Device Component; Component Missing; Detachment of Device or Device Component

  ON 23RD FEBRUARY 2024, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES - 100380A0 - LEG HOLDER. AS IT WAS STATED, ALL FOUR PAN HEAD SCREWS ON THE SHOE JOINT TAPING OF THE LEG HOLDER WERE FOUND TO BE MISSING ON BOTH SIDES. BOOT SECURING PLATE HAD BECOME DETACHED FROM ASSEMBLY WHEN THE STAFF PICKED THE DEVICE TO MOVE IT. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE USE OF A LEG HOLDER WITH MISSING SCREWS DURING SURGERY WHICH COULD RESULT IN UNINTENDED CHANGE IN PATIENT POSITION OR PATIENT'S FALL, WAS TO OCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18844140 ↗
• MalfunctionNov 22, 2023Component Missing; Component Missing

  ON 24TH OCTOBER 2023, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES - 100380A0 - LEG HOLDER. AS IT WAS STATED, THE SCREWS ON THE SHOE JOINT TAPING OF THE NEWLY DELIVERED LEG HOLDER WERE MISSING. THE ISSUE WAS NOT NOTICED DURING HANDING OVER TO THE CUSTOMER AND WAS DISCOVERED BY NURSES. IT HAS BEEN CONCLUDED THAT IT IS POSSIBLE THE MALFUNCTION WILL NOT BE DETECTED DURING THE PRE-USE CHECK. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE LEG HOLDER BREAKS DUE TO THE MISSING SCREWS AND, AS A CONSEQUENCE, THE LEG OF THE PATIENT WILL FALL DOWN WITH THE RESULT OF NERVE OVERSTRETCHING, WAS TO OCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18190349 ↗