Trabecular Metal™ TMM4B11Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024018815), received between May 14, 2021 and Aug 19, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Fracture” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22841424 ↗
• InjuryJun 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DENTAL IMPLANT LOCATED IN DENTAL POSITION NUMBER #15 FAILED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 22303536 ↗
• InjuryDec 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT COMPLAINED FOR AREA BEING SORE AND ACHY, PA REVEALED INFECTION AROUND IMPLANT SITE. IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, ABSCESS. TOOTH NUMBER: 11 UNIVERSAL.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 18411341 ↗
• InjuryDec 14, 2022Fracture; Fracture

  DOCTOR REPORTED IMPLANT FRACTURE WITH TRAUMA AT TOOTH SITE 46. PATIENT CAME ON (B)(6) 2022 WITH FRACTURED IMPLANT, THE CROWN IS AT MEDICAL CENTER. THE REMAINING PART OF THE IMPLANT REMAINS IN THE JAW. PATIENT HAS BEEN RESCHEDULED FOR REMOVAL OF THE REMAINING PART OF THE FRACTURED IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15980928 ↗
• InjuryMay 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IMPLANT LACKED PRIMARY STABILITY DURING THE PLACEMENT PROCEDURE. NO OTHER IMPLANT WAS PLACED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11824740 ↗