Trabecular Metal™ TMMB11Recalls & 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
- 8
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00889024018877), received between Nov 2, 2020 and Feb 17, 2026 — classified as 7 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem4
- Fracture4
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Osteolysis3
- Unspecified Infection2
- Discomfort1
- No Code Available1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #33 AND #35 WERE REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24370698 ↗InjuryDec 17, 2025Adverse 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: Osteolysis
MAUDE report 23831506 ↗InjuryDec 1, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23678578 ↗InjuryApr 17, 2025Fracture; Fracture
IT WAS REPORTED AN IMPLANT FRACTURED AT THE BODY PART IMPLANTED AT TOOTH SITE # 36. IMPLANT WAS COMPLETELY REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21856836 ↗InjuryMar 18, 2024Fracture; Fracture
IMPLANT FOR TOOTH SITE #7 WAS PLACED IN 2016. #7 WAS FRACTURED AT THE MIDDLE OF IMPLANT BODY WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: DISCOMFORT.
Patient problems: Discomfort
MAUDE report 18925937 ↗MalfunctionMay 5, 2023Fracture; Fracture
IT WAS REPORTED THAT THE IMPLANT FRACTURED AT THE SAME TIME AS THE SCREW. TOOTH SITE #12.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16881883 ↗InjuryJan 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO BONE LOSS AT THE IMPLANT SITE.
Patient problems: Osteolysis
MAUDE report 16199164 ↗InjuryNov 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Code Available; Unspecified Infection
MAUDE report 10769342 ↗
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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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