Skip to content

Trabecular Metal 20-8075-004-01Recalls & reported problems

Orthosoft Inc · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024304130), received between Dec 21, 2022 and May 24, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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

  • Detachment of Device or Device Component2
  • Mechanical Problem1

Patient problems

  • Failure of Implant2
  • Pain2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SIX(6) YEARS POST IMPLANTATION DUE DISASSOCIATION AND PAIN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Patient problems: Failure of Implant; Pain

    MAUDE report 16995215 ↗
  • InjuryDec 21, 2022Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SIX(6) YEARS POST IMPLANTATION DUE DISASSOCIATION AND PAIN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Patient problems: Failure of Implant; Pain

    MAUDE report 16021752 ↗

Other Orthopaedic Surgical Planning And Instrument Guides devices

All Orthopaedic Surgical Planning And Instrument Guides devices →

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