Trabecular Metal™ TMM4B13Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889024018822), received between Feb 28, 2020 and Jun 3, 2024 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE 26 WAS REMOVED DUE TO PERI-IMPLANTITIS. PROCEDURE WAS NOT COMPLETED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19445714 ↗
• InjuryApr 12, 2024Fracture; Fracture

  IT WAS REPORTED AN IMPLANT FRACTURED AT THE BOTTOM DURING SURGICAL PROCEDURE AT TOOTH SITE #15 APPLYING NORMAL TORQUE. PROCEDURE WAS COMPLETE WITH ANOTHER IMPLANT. BOTH PARTS OF THE IMPLANT WERE REMOVED. PATIENT SUFFERED 1 HOUR DELAY AT THE TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19100137 ↗
• InjuryMar 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 9 WAS REMOVED DUE TO PERI-IMPLANTITIS, WITH ASSOCIATED ABSCESS AND EDEMA. IT WAS DETERMINED IMPLANT #9 HAD A HOPELESS PROGNOSIS DUE TO SEVERE BONE LOSS AND PERI-IMPLANTITIS. IT WAS RECOMMENDED IT BE REMOVED, AND IT WAS REMOVED.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 18823443 ↗
• InjuryFeb 11, 2021Fracture; Fracture

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

  Patient problems: No Information

  MAUDE report 11316949 ↗
• 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 IN THE OSTEOTOMY DUE TO THE LACK OF PRIMARY STABILITY. BONE LOSS WAS INDICATED AS A RESULT OF THE EVENT. PATIENT WILL RETURN FOR ADDITIONAL VISITS FOR NEW IMPLANT. TOOTH #10.

  Patient problems: No Code Available

  MAUDE report 10106659 ↗
• InjuryFeb 28, 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 LACK OF PRIMARY STABILITY.

  Patient problems: No Information

  MAUDE report 9771295 ↗