Hip Instruments 01.32.10.0006Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630040745635), received between May 22, 2019 and May 22, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 22, 2019Fracture; Positioning Problem

  DURING THE PRIMARY HIP SURGERY AND AFTER REAMING THE ACETABULUM TO 47MM, THE SURGEON TAPPED THE 48MM SIZER WITH A MALLET AND THE MEDIAL FLOOR OF THE ACETABULUM FRACTURED. THE SURGEON IMPLANTED A BONE GRAFT AND A 48MM MPACT MULTI-HOLE CUP WITH SCREWS. AS THE SURGEON WAS IMPACTING THE LINER, THE CUP MOVED. THE SURGEON THEN REMOVED THE 48MM CUP AND RE-GRAFTED AND IMPACTED THE GRAFT. THE SURGEON RE-IMPLANTED THE 48MM CUP WITH SCREWS AND UPON IMPACTING THE LINER, THE CUP MOVED AGAIN. THE SURGEON DECIDED TO REMOVE THE 48MM MPACT MULTI-HOLE CUP AND LINER AND IMPLANT ANOTHER COMPANY'S CUP AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT HAS OSTEOPENIA.

  Patient problems: Hip Fracture

  MAUDE report 8631621 ↗