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AESCULAP ND060Recalls & reported problems

Aesculap AG · IMPACTION INSTR.F/HIP PROSTHESES/HEADS · Class 1

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046963743659), received between Feb 9, 2022 and Feb 9, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1
  • Fracture1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • InjuryFeb 9, 2022Break; Fracture; Break; Fracture

    IT WAS REPORTED TO AESCULAP AG THAT A IMPACTION INSTR.F/HIP PROSTHESES/HEADS (PART # ND060) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE PLASTIC COMPONENT BURST APART DURING A HIP IMPLANTATION PROCEDURE. THERE WAS AN ADDITIONAL INTERVENTION REQUIRED. SURGICAL DELAY OF 10 MINUTES OCCURRED DUE TO REMOVAL OF SPLINTERS. ADDITIONAL INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE XC (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13501662 ↗

Other IMPACTOR devices

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