Trabecular Metal™ TMMWB13Recalls & 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
- 9
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00889024018921), received between Feb 24, 2021 and Dec 16, 2025 — classified as 9 injuries.
The most frequently reported specific device problem is “Fracture” (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. 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 Problem8
- Fracture1
- Mechanical Problem1
Patient problems
- Osteolysis5
- Pain3
- Unspecified Infection3
- Failure of Implant1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Osteolysis
MAUDE report 23822249 ↗InjurySep 18, 2024Adverse 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 20245676 ↗InjuryMay 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES # 46 WASREMOVED DUE TO MEDICAL BONE LOSS.
Patient problems: Osteolysis
MAUDE report 14547558 ↗InjuryMay 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITES #45 WAS REMOVED DUE TO MEDICAL BONE LOSS.
Patient problems: Osteolysis
MAUDE report 14547454 ↗InjuryNov 18, 2021Fracture; Mechanical Problem; Fracture; Mechanical Problem
IT WAS REPORTED THAT THE ABUTMENT AND IMPRESSION POST WERE UNABLE TO SEAT IN THE IMPLANT. FURTHER INVESTIGATION BY THE DOCTOR FOUND THAT THE INTERNAL COMPONENTS OF THE IMPLANT WERE FRACTURED AND THE INTERNAL HEX HAD BEEN STRIPPED.
Patient problems: Failure of Implant
MAUDE report 12838235 ↗InjuryOct 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.
Patient problems: Pain; Unspecified Infection
MAUDE report 12674492 ↗InjuryOct 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.
Patient problems: Pain; Unspecified Infection
MAUDE report 12674428 ↗InjuryJul 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Pain
MAUDE report 12100910 ↗InjuryFeb 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #5 HAD TO BE REMOVED DUE TO INFECTION AND BONE LOSS AT THE SITE.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 11373630 ↗
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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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