Trabecular Metal™ TMT4B11Recalls & 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
Quick summary
This ZimVie Trabecular Metal dental implant is a screw-shaped root-form implant used to replace missing teeth. The 30 reports mostly describe bone loss around the implant (osteolysis), infections, pain, and implants breaking at the metal junction, sometimes requiring surgical removal. There are 27 injuries and no deaths. 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
- 30
- Deaths reported
- 0
- Injuries reported
- 27
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00889024018945), received between Dec 4, 2019 and Dec 15, 2025 — classified as 27 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (10 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem19
- Fracture10
- Component Missing1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- Osteolysis9
- Pain8
- Unspecified Infection8
- Inflammation4
- No Information3
- Abscess2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
InjuryDec 15, 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 #24 AND #25 WERE REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 23803318 ↗InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE WAS NATURAL OSTEOLYSIS AT THE IMPLANT BODY TRABECULAR METAL AT TOOTH SITE #12.
Patient problems: Osteolysis
MAUDE report 23693885 ↗InjuryMar 13, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21597804 ↗InjuryMar 5, 2025Fracture; Fracture
IT WAS REPORTED THAT THE TRABECULAR METAL IMPLANT AT TOOTH SITE #5 FRACTURED AT THE TANTALUM/TITANIUM INTERFACE AND WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, LOSS OF RESTORATION.
Patient problems: No Clinical Signs, Symptoms or Conditions; Pain
MAUDE report 21527195 ↗MalfunctionFeb 20, 2025Fracture; Fracture
IT WAS REPORTED THAT THE IMPLANT FRACTURED AND IT WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21426383 ↗InjuryAug 12, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Pain
MAUDE report 19966661 ↗InjuryJul 24, 2024Adverse 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: Osteolysis; Pain; Unspecified Infection
MAUDE report 19814539 ↗InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES 16 AND 26 WERE REMOVED DUE TO PERI-IMPLANTITIS. PROCEDURE WAS NOT COMPLETED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19456816 ↗InjuryMay 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WASN'T ABLE TO BE PLACED DUE TO LACK OF TORQUE AND NERVE INJURY.
Patient problems: Nerve Damage
MAUDE report 19330629 ↗InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #13 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19215255 ↗InjuryApr 29, 2024Adverse 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. TOOTH SITE # 16.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19201062 ↗InjuryNov 16, 2023Fracture; Fracture
THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN POSITION NUMBER #23 FAILED BECAUSE IT FRACTURED THROUGH THE BODY. THE DOCTOR NOTED APPARENT MOBILITY, AND UPON OPENING, REALIZED THAT THE IMPLANT WAS COMPLETELY FRAGMENTED IN HALF. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. THE DOCTOR REPORTED PAIN AND INFLAMMATION.
Patient problems: Inflammation; Pain
MAUDE report 18149157 ↗InjuryOct 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
INFECTION WAS REPORTED AT TOOTH SITE #2 AND THE IMPLANT WAS REMOVED ON (B)(6) 2023.
Patient problems: Unspecified Infection
MAUDE report 17981273 ↗InjurySep 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CUSTOMER REPORTED DURING THE UNCOVER, IMPLANT CAME OUT, BONE LOSS. I HAD TO DO BONE GRAFT THE AREA, TOOTH 29.
Patient problems: Osteolysis
MAUDE report 17709962 ↗InjuryJun 6, 2023Fracture; Fracture
NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17072801 ↗InjuryJan 26, 2023Fracture; Fracture
NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16250730 ↗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 16152673 ↗MalfunctionMay 13, 2022Component Missing; Component Missing
IT WAS REPORTED THAT THE IMPLANT WAS MISSING FROM THE PACKAGE. CUSTOMER CONFIRMED ANOTHER IMPLANT WAS PLACED IN THE SAME SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14397497 ↗InjuryMay 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS PLACED UNDER GENERAL ANESTHESIA. INTRA OP XRAY INCONCLUSIVE. POST OP PANO REVEALED INCORRECT PLACEMENT. DUE TO NEEDING GENERAL ANESTHESIA DUE TO SEVERE DENTAL PHOBIA, 7 DAYS BETWEEN IMPLANT AND EXPLANT REQUIRED. TOOTH 11. THE SITE WAS GRAFTED WITH ALLOGRAFT TOGETHER WITH ORIGINAL IMPLANT PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14321851 ↗InjuryNov 17, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12829448 ↗InjuryOct 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS HAVING CONSTANT PAIN AND WANTED THE IMPLANT REMOVED. IMPLANT #9 WAS REMOVED AND THE AREA WAS GRAFTED. THE PATIENT IS NOT RETURNING FOR FUTURE IMPLANT PLACEMENT. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Pain
MAUDE report 12572706 ↗InjuryAug 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
UPON FOLLOW UP WITH CUSTOMER, IT WAS CONFIRMED THAT THERE WAS NO STABILITY AT PLACEMENT DUE TO PATIENT HAD INSUFFICIENT BONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12387613 ↗InjuryMar 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 SITE # 20 FAILED DUE TO SIGNIFICANT BONE LOSS AT THE IMPLANT SITE AND WAS REMOVED. PER INDICATED: REPORTS BONE LOSS NO GRAFT SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: NO INJURY TO PATIENT OTHER THAN IMPLANT BEING REMOVED. NO PERMANENT IMPAIRMENT. ADDITIONAL APPOINTMENT REQUIRED: PATIENT WILL RETURN IN 90 DAYS TO SEE IF HEALING WILL ALLOW NEW PLACEMENT. SYMPTOMS AS A RESULT OF THE EVENT: BONE LOSS.
Patient problems: Osteolysis
MAUDE report 11564831 ↗MalfunctionMar 8, 2021Fracture; Fracture
IT WAS REPORTED THAT IMPLANT WAS LOOSE AND WHEN REMOVED, THE IMPLANT WAS SPLIT OFF WHERE TRABECULAR METAL STARTS. THE OTHER HALF IS STILL IN THE PATIENT FULLY INTEGRATED AT SITE #3. AS A RESULT OF THE EVENT NO INJURY TO THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11434609 ↗InjuryMar 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTS THAT THE TMT4B11 IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. BONE LOSS, ABSCESS, INFLAMMATION AND APICAL PERFORATION OF THE BUCCAL CORTICAL BONE IS ALSO REPORTED. TOOTH SITE # 12. THE OSTEOTOMY AND DEFECT WERE THOROUGHLY DEBRIDED, A SECOND FIXTURE WAS PACED ALONG WITH ALLOGRAFT BONE.
Patient problems: Abscess; Inflammation; Osteolysis; Unspecified Infection
MAUDE report 11423858 ↗
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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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