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INSTRUMENT 0580-355-0Recalls & reported problems

Howmedica Osteonics Corp. · EXETER MODULAR RASP CDH (S) · Class 2

All models of INSTRUMENT (131)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327207675), received between Jun 17, 2020 and Jun 17, 2020 — classified as 1 malfunction.

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

Device problems

  • Fracture1

Patient problems

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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 17, 2020Fracture; Fracture

    IT WAS REPORTED THAT THE TRUNNION BROKE OFF OF THE SIZE 0 EXETER RASP IN PATIENT AND THAT IT WAS NOT POSSIBLE TO REASSEMBLE RASP HANDLE ONTO THE RASP.

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

    MAUDE report 10161834 ↗

Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices

All Prosthesis, hip, semi-constrained, metal/polymer, cemented devices →

Sources and updates

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