Trabecular Metal™ TMT6B13Recalls & reported problems
ZimVie US Corp LLC · Class 2 · Implant
All models of Trabecular Metal (24)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00889024018983), received between May 20, 2022 and Apr 22, 2023 — classified as 2 injuries.
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 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Pain2
- Discomfort1
- Osteolysis1
- Swelling/ Edema1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS SEEN IN THE OFFICE FOR SWELLING OF GUM TISSUE IN IMPLANT AREA AT TOOTH LOCATION #19. PROCEDURE FOR DEBRIDEMENT VS REMOVAL WAS PERFORMED BUT THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS (INFECTION AND BONE LOSS). SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND EDEMA.
Patient problems: Osteolysis; Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 16792734 ↗InjuryMay 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Discomfort; Pain
MAUDE report 14454874 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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