Knee positioning device 100484A0Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046768001930), received between Nov 23, 2023 and Nov 23, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• MalfunctionNov 23, 2023Device Slipped; Device Dislodged or Dislocated; Device Slipped; Device Dislodged or Dislocated

  ON 16TH NOVEMBER 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES - 100484A0 - KNEE POSITIONING DEVICE. AS IT WAS STATED, UNINTENDED DOWN MOVEMENT OF THE DEVICE OCCURRED TWICE DURING THE ACS KNEE PROSTHESIS SURGERY. THERE WAS A SHORT DELAY AND THE POSITION OF THE OPERATED KNEE HAD TO BE ADJUSTED. THE PATIENT WAS NOT HARMED AND THE OPERATION CONTINUED. LATER ON, IT WAS CONFIRMED THE PATIENT WAS ANESTHETIZED WHEN THE ISSUE OCCURRED AND THE DELAY LASTED APPROXIMATELY THREE MINUTES EACH TIME. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY UNINTENDED DOWNWARD MOVEMENT OF THE DEVICE DURING THE SURGERY, WAS TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18199211 ↗