Trabecular Metal™ TMTWB13Recalls & reported problems
ZimVie US Corp LLC · Class 2 · Implant
All models of Trabecular Metal (24)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024019058), received between Oct 30, 2019 and Oct 5, 2020 — classified as 3 injuries.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Patient-Device Incompatibility1
Patient problems
- No Information3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryOct 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTS THEY WERE UNABLE TO ACHIEVE PRIMARY STABILITY WITH THE TMTWB13 IMPLANT IN SITE # 18.
Patient problems: No Information
MAUDE report 10627291 ↗InjuryApr 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN IMPLANT WAS UNABLE TO BE PLACED INTO OSTEOTOMY. IMPLANT WAS SPINNING AND DID NOT ACHIEVE PRIMARY STABILITY AND IT WAS REMOVED. DOCTOR TRIED A LARGER IMPLANT (TMTWB13) AND IT DID NOT ACHIEVE STABILITY. SECOND IMPLANT WAS ALSO REMOVED. TOOTH LOCATION 4. SITE WAS BONE GRAFTED.
Patient problems: No Information
MAUDE report 9995464 ↗InjuryOct 30, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED THAT DOCTOR SUSPECTED ALLERGIC REACTION AND IMPLANT (TMTWB13) WAS REMOVED. SITE WAS BONE GRAFTED. TOOTH LOCATION 14.
Patient problems: No Information
MAUDE report 9257216 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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