Trabecular Metal™ TMM6B11Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024018846), received between Jun 21, 2021 and Nov 24, 2023 — classified as 4 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem4
Patient problems
- Unspecified Infection3
- Inflammation2
- Osteolysis2
- Abscess1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryNov 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION AT IMPLANT TOOTH SITE #3. THEREFORE, THE IMPLANT WAS REMOVED.
Patient problems: Unspecified Infection
MAUDE report 18207444 ↗InjuryNov 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS UNABLE TO BE PLACED DUE TO A LACK OF PRIMARY STABILITY. THE BONE WAS TOO SOFT RESULTING IN THE IMPLANT BEING A SPINNER. TOOTH #3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12804963 ↗InjuryAug 14, 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: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 12322193 ↗InjuryJun 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #3 LOST INTEGRATION 11 MONTHS AFTER PLACEMENT DUE TO PERIIMPLANTITIS. THE IMPLANT BECAME LOOSE IN THE PATIENTS MOUTH AND WAS REMOVED BY HAND. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND INFLAMMATION. SITE WAS GRAFTED WITH ALLOGRAFT PRIOR TO ORIGINAL PLACEMENT. TOOTH SITE # 3 (UNIVERSAL.)
Patient problems: Abscess; Inflammation; Osteolysis; Unspecified Infection
MAUDE report 12037392 ↗
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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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