Trabecular Metal™ TMTB11Recalls & reported problems
ZimVie US Corp LLC · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This ZimVie Trabecular Metal dental implant sits in the jaw to hold replacement teeth. The 24 reports mostly describe infection and inflammation around the implant, with pain, swelling and bone loss, often leading to removal, plus one report of a mount that would not release during placement. The reports mention no deaths and 23 injuries, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 24
- Deaths reported
- 0
- Injuries reported
- 23
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00889024019003), received between Mar 20, 2020 and Feb 10, 2026 — classified as 23 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (2 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem19
- Fracture2
- Patient-Device Incompatibility2
- Separation Failure1
Patient problems
- Unspecified Infection12
- Pain9
- Osteolysis8
- Inflammation7
- No Clinical Signs, Symptoms or Conditions4
- Hypersensitivity/Allergic reaction2
- No Code Available2
- No Information2
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #42 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION AROUND THE IMPLANT, PATIENT'S FACE WAS SWOLLEN.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 24308838 ↗MalfunctionJan 29, 2026Separation Failure
IT WAS REPORTED THAT, DURING THE ATTEMPTED PLACEMENT OF THE IMPLANT AT TOOTH SITE #18, THE MOUNT COULD NOT DISENGAGE FROM THE IMPLANT. THE IMPLANT TORQUED TO 35NCM. A DIFFERENT IMPLANT HAD TO BE USED TO REPLACE THE IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24210779 ↗InjuryOct 27, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Hypersensitivity/Allergic reaction; Pain
MAUDE report 23388826 ↗InjuryOct 27, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Hypersensitivity/Allergic reaction; Pain
MAUDE report 23388790 ↗InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #5 AND #12 BECAME SYMPTOMATIC DURING PROSTHETIC STAGES OF THE TREATMENT. THE IMPLANTS WERE REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22679650 ↗InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #5 AND #12 BECAME SYMPTOMATIC DURING PROSTHETIC STAGES OF THE TREATMENT. THE IMPLANTS WERE REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22679456 ↗InjuryJun 29, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Inflammation; Osteolysis
MAUDE report 17231817 ↗InjuryJan 12, 2023Adverse 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: Inflammation; Pain; Unspecified Infection
MAUDE report 16152399 ↗InjuryJan 12, 2023Adverse 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: Inflammation; Pain; Unspecified Infection
MAUDE report 16152263 ↗InjuryJan 12, 2023Adverse 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: Inflammation; Pain; Unspecified Infection
MAUDE report 16152103 ↗InjuryJan 12, 2023Adverse 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: Inflammation; Pain; Unspecified Infection
MAUDE report 16152086 ↗InjuryJun 1, 2022Adverse 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 AN INFECTION AT THE SITE. TOOTH #24.
Patient problems: Unspecified Infection
MAUDE report 14569476 ↗InjuryMay 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #46 WAS REMOVED DUE TO MEDICAL BONE LOSS.
Patient problems: Osteolysis
MAUDE report 14521242 ↗InjuryApr 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS HAVING PAIN AROUND THE IMPLANT AT TOOTH LOCATION #7. THE IMPLANT WAS ALSO MOBILE AND WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Pain; Unspecified Infection
MAUDE report 14238691 ↗InjuryFeb 16, 2022Adverse 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 PERI-IMPLANTITIS WITH BONE LOSS. PATIENT WILL NOT RETURN FOR ADDITIONAL APPOINTMENTS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 13543581 ↗InjuryDec 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE IMPLANT AT AN UNKNOWN TOOTH SITE LACKED PRIMARY STABILITY, AND WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12912013 ↗InjuryAug 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12288642 ↗InjuryJul 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12246421 ↗InjuryJun 24, 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 12063088 ↗InjuryMar 16, 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: Osteolysis; Pain; Purulent Discharge; Unspecified Infection
MAUDE report 11494347 ↗InjuryFeb 11, 2021Adverse 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 TMTB11 IMPLANT IN TOOTH SITE #12.
Patient problems: No Information
MAUDE report 11314132 ↗InjuryJun 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTS THAT PATIENT WAS SEEN FOR UNCOVER AND TORQUE TEST HOWEVER THE TMTB11 IMPLANT HAD SOME INFECTION AROUND IT AND THE PATIENT WAS IN PAIN. PERI IMPLANTITIS IS REPORTED. THE SITE WAS GRAFTED WITH ALLOGRAFT PRIOR TO IMPLANT PLACEMENT. TOOTH SITE # 8.
Patient problems: No Code Available; Pain; Unspecified Infection
MAUDE report 10138442 ↗InjuryApr 2, 2020Fracture; Fracture
IT WAS REPORTED THAT DURING A CLINICAL EXAM CLINICIAN DISCOVERED A FRACTURED IMPLANT AND THEREFORE THE ABUTMENT BECAME LOOSE. NO INDICATION IF THE PATIENT WILL RETURN NO FUTURE APPOINTMENT REPORTED. NO INJURY TO PATIENT OTHER THAN IMPLANT BEING REMOVED. NO PERMANENT IMPAIRMENT AND NO DELAY IN PROCEDURE.
Patient problems: No Code Available
MAUDE report 9917081 ↗InjuryMar 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AT PLACEMENT BONE WAS SOFT, IMPLANT NOT STABLE AT TOOTH SITE # 5 AND HAD TO BE REMOVED.
Patient problems: No Information
MAUDE report 9860463 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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