MODULAR MICROPLASTY® CUP IMPACTOR 31-400603Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00880304458130), received between Nov 17, 2021 and May 25, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 25, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A HIP SURGERY, THE GEAR IN THE INSTRUMENT FRACTURED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14499642 ↗
• MalfunctionMay 18, 2022Fracture; Fracture

  IT WAS REPORTED WHILE INSERTING THE ACETABULAR CUP THE INNER GEAR OF THE CUP INSERTER BROKE. ALL ITEMS WERE LOCATED AND CHECKED UNDER FLURO TO MAKE SURE NOTHING WAS LEFT IN THE JOINT SPACE. NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14427879 ↗
• MalfunctionNov 17, 2021Fracture; Fracture

  NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12829843 ↗