Trabecular Metal™ TMMB10Recalls & 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
- 13
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00889024018860), received between Feb 21, 2020 and May 12, 2026 — classified as 13 injuries.
The most frequently reported specific device problem is “Fracture” (6 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem7
- Fracture6
- Patient-Device Incompatibility1
Patient problems
- No Information4
- Osteolysis4
- No Clinical Signs, Symptoms or Conditions3
- Unspecified Infection3
- Pain2
- Hypersensitivity/Allergic reaction1
- Inflammation1
- Nerve Damage1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN DENTAL POSITION NUMBER #17 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25147535 ↗InjuryDec 4, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23715381 ↗InjuryDec 4, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23715269 ↗InjuryApr 8, 2024Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Hypersensitivity/Allergic reaction; Osteolysis; Unspecified Infection
MAUDE report 19062318 ↗InjuryMar 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH #26 WAS REMOVED DUE TO BONE LOSS . ABSCESS WAS REPORTED AS A RESULT OF THE EVENT. PATIENT WOULD HAVE TO RETURN TO PLACE A NEW IMPLANT.
Patient problems: Osteolysis
MAUDE report 18896120 ↗InjuryOct 3, 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: Nerve Damage; Pain; Paresthesia
MAUDE report 17859729 ↗InjuryNov 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 BONE LOSS AND INFECTION. TOOTH SITE # 13 (UNIVERSAL). THE SITE WAS GRAFTED TOGETHER WITH ORIGINAL IMPLANT PLACEMENT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 15809186 ↗InjuryJul 8, 2022Fracture; Fracture
DOCTOR REPORTED THAT AN IMPLANT FRACTURE AT TOOTH SITE #32.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14956168 ↗InjuryNov 29, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Inflammation; Pain
MAUDE report 12881666 ↗InjuryFeb 8, 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 14 LACKED PRIMARY STABILITY WHEN PLACING AND WAS REMOVED. ADDITIONAL APPOINTMENT REQUIRED: YES, TO PLACE A NEW IMPLANT.
Patient problems: No Information
MAUDE report 11291985 ↗InjuryApr 10, 2020Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Information
MAUDE report 9950130 ↗InjuryMar 20, 2020Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Information
MAUDE report 9860475 ↗InjuryFeb 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT COULD NOT GET PRIMARY STABILITY DUE TO BONE LOSS. THE IMPLANT WAS REMOVED AND BONE GRAFT PLACED FOR FUTURE IMPLANT REPLACEMENT.
Patient problems: No Information
MAUDE report 9738541 ↗
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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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