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Conformis Hip System 1080-558Recalls & reported problems

Conformis, Inc. · IMPACTOR, FEMORAL HEAD · Class 1

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 00850268007521), received between Jul 26, 2019 and Jul 26, 2019 — classified as 1 malfunction.

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
  • Detachment of Device or Device Component1
  • Physical Resistance/Sticking1

Patient problems

  • 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.

  • MalfunctionJul 26, 2019Break; Detachment of Device or Device Component; Physical Resistance/Sticking

    IT WAS REPORTED THAT THE SURGEON WAS USING THE HEAD IMPACTOR TO REMOVE THE HEAD TRIAL WHICH GOT STUCK TO THE TRUNION OF THE FEMORAL IMPLANT RESULTING IN THE PLASTIC OF THE IMPACTOR BREAKING OFF. THE ISSUE WAS RESOLVED AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8832899 ↗

Other Orthopedic Manual Surgical Instrument 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.