DeRoyal 89-5400Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00749756635929), received between Dec 11, 2019 and Jan 13, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (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.

• MalfunctionJan 13, 2020Component Missing; Device Misassembled During Manufacturing /Shipping; Manufacturing, Packaging or Shipping Problem; Component Missing; Device Misassembled During Manufacturing /Shipping; Manufacturing, Packaging or Shipping Problem

  A CONVENIENCE KIT CAME WITH FOURTEEN LAP PADS INSTEAD OF FIFTEEN. THIS WAS IDENTIFIED DURING THE INITIAL COUNT. NO HARM TO THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9580996 ↗
• MalfunctionDec 11, 2019Manufacturing, Packaging or Shipping Problem

  WHILE SETTING UP OPERATING ROOM FOR TOTAL KNEE ARTHROPLASTY, IT WAS DISCOVERED THAT THE DEROYAL MIRIAM TOTAL KNEE PACK CAME WITH 14 LAP PADS, INSTEAD OF 15. THIS WAS IDENTIFIED & RECORDED PROPERLY DURING INITIAL COUNT. CASE PROCEEDED AS NORMAL, NO HARM TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9451044 ↗