Trabecular Metal™ TMMB13Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00889024018884), received between Mar 17, 2020 and Mar 18, 2025 — classified as 7 injuries.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #11 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 21635045 ↗
• InjuryJul 29, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE IMPLANT HAD TO BE REMOVED DUE TO BECOMING FRACTURED. A NEW IMPLANT WAS PLACED AFTER REMOVAL.

  Patient problems: Failure of Implant

  MAUDE report 15130477 ↗
• InjuryJun 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT COULD NOT BE PLACED DUE TO FRACTURE OF THE PATIENT'S BONE. THE SITE WAS GRAFTED FOR FUTURE PLACEMENT.

  Patient problems: Bone Fracture(s)

  MAUDE report 14652505 ↗
• InjuryMay 13, 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 AT THE IMPLANT SITE.

  Patient problems: Abscess; Inflammation; Osteolysis; Swelling/ Edema

  MAUDE report 14395192 ↗
• InjuryJul 15, 2020Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Information

  MAUDE report 10279542 ↗
• InjuryJun 1, 2020Adverse 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 THE LACK OF PRIMARY STABILITY. BONE LOSS WAS INDICATED AS A RESULT OF THE EVENT. PATIENT WILL RETURN FOR IMPLANT PLACEMENT AT A FUTURE VISIT. TOOTH #10.

  Patient problems: No Code Available

  MAUDE report 10106647 ↗
• InjuryMar 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED HYPERESTHESIA. THE IMPLANT TMMB13 IN DENTAL SITE 11 WAS REMOVED. DELAY IN THE PROCEDURE WAS REPORTED.

  Patient problems: Increased Sensitivity

  MAUDE report 9841110 ↗