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