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INSTRUMENT 1440-2010Recalls & reported problems

Howmedica Osteonics Corp. · CURVED CUP BOLT IMPACTOR · Class 2

Adverse event reports
5
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327010312), received between Dec 22, 2017 and Aug 3, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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

Device problems

  • Break4
  • Fracture4
  • Insufficient Device Problem Information1

Patient problems

  • No Known Impact Or Consequence To Patient4
  • No Clinical Signs, Symptoms or Conditions1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 3, 2020Fracture; Insufficient Device Problem Information; Fracture; Insufficient Device Problem Information

    PRIMARY PROCEDURE, RIGHT HIP. IT WAS REPORTED THAT THE IMPACTOR BOLT BECAME STUCK IN THE SHELL, AND THAT THE IMPACTOR SHEARED OFF WHERE THE HANDLE MEETS THE CURVED PART OF THE IMPACTOR. ALL DEVICES (INCLUDING THE SHELL) WERE REMOVED FROM THE PATIENT AND ANOTHER SHELL WAS IMPLANTED. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 2 MINUTES. REP MAY BE ABLE TO PROVIDE SOME ADDITIONAL PATIENT INFORMATION, OTHERWISE CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

    Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

    MAUDE report 10355366 ↗
  • MalfunctionApr 16, 2019Break; Break

    CUP IMPACTOR BROKE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8520543 ↗
  • MalfunctionDec 22, 2017Break; Fracture; Break; Fracture

    CURVED CUP IMPACTOR BROKE DURING TAP IN THE SOCKET. REPLACEMENT WAS AVAILABLE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7144980 ↗
  • MalfunctionDec 22, 2017Break; Fracture; Break; Fracture

    CURVED CUP IMPACTOR BROKE DURING TAP IN THE SOCKET. REPLACEMENT WAS AVAILABLE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7144956 ↗
  • MalfunctionDec 22, 2017Break; Fracture; Break; Fracture

    CURVED CUP IMPACTOR BROKE DURING TAP IN THE SOCKET. REPLACEMENT WAS AVAILABLE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7144951 ↗

Other Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish devices

All Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.