Trabecular Metal™ TMT4B13Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00889024018952), received between Nov 22, 2019 and May 1, 2026 — classified as 16 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO BONE LOSS. PATIENT RETURNED TO CLINIC WITH SYMPTOMS OF IMPLANT SITE. RADIOGRAPHIC REVEALS BONE LOSS AROUND IMPLANT. IMPLANT REMOVED, NO IMPLANT REPLACEMENT AT THIS TIME. TOOTH NUMBER 27.

  Patient problems: Osteolysis

  MAUDE report 25057515 ↗
• InjuryAug 18, 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 22834218 ↗
• InjuryMar 6, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #37 WAS REMOVED DUE TO IMPLANT FRACTURE DURING PLACEMENT AND WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21541208 ↗
• InjuryJun 4, 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 23 WAS REMOVED DUE TO PERI-IMPLANTITIS. DISCOMFORT WAS REPORTED AS A RESULT OF THE EVENT. PROCEDURE WAS NOT COMPLETED.

  Patient problems: Discomfort; Osteolysis; Unspecified Infection

  MAUDE report 19456751 ↗
• InjuryOct 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT EXTRACTION OF IMPLANT WAS DONE, ALONG WITH BONE GRAFT USING ALLOGRAFT. TOOTH 9. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17857071 ↗
• InjuryOct 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LPT (LASER PERIODONTAL THERAPY) WAS DONE AROUND THE IMPLANT AT TOOTH LOCATION #9 DUE TO PERI-IMPLANTITIS. THE IMPLANT REMAINED IMPLANTED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17851435 ↗
• InjuryFeb 9, 2023Fracture; Fracture

  THE PATIENT REPORTED THAT THE IMPLANT FRACTURED. THE PATIENT REPORTED PAIN AND WANTS THE IMPLANT REMOVED AND REPLACED. TOOTH LOCATION UNKNOWN.

  Patient problems: Pain

  MAUDE report 16334777 ↗
• InjuryJan 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS A CHRONIC INFECTION IN THE IMPLANT AREA AFTER ABOUT FIVE (5) YEARS OF USE. THE AFFECTED DENTAL POSITIONS ARE: #11 #21, #16, #26 AND #27. THE DOCTOR REPORTS: PAIN AND INFLAMMATION. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT COMPLETED WITH THE PLACEMENT OF OTHER IMPLANTS.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 16152377 ↗
• InjuryJun 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED RAPID BONE LOSS AROUND IMPLANT DESPITE PRIMARY STABILITY AT PLACEMENT TO CRESTAL BONE LEVEL LEAVING IMPLANT NON- RESTORABLE IN CURRENT STATE. REMOVED, GRAFTED. TOOTH 10.

  Patient problems: Osteolysis

  MAUDE report 14685526 ↗
• MalfunctionFeb 23, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE TRABECULAR METAL IMPLANT GOT BROKEN DURING SURGERY. NO OTHER IMPLANT PLACE, NO INJURY OR DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13585664 ↗
• InjuryJan 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT THE IMPLANT AT TOOTH LOCATION #9 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOM AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 13176540 ↗
• InjuryNov 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY CUSTOMER THAT THE IMPLANT WAS UNABLE TO BE PLACED AND WAS REMOVED. SURGERY WAS COMPLETED USING ANOTHER IMPLANT. TOOTH LOCATION UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12860602 ↗
• InjuryNov 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IMPLANT AT TOOTH SITE # 13 (UNIVERSAL) WAS TORQUE TESTED SUCCESSFULLY AND IT WAS INTEGRATED, HOWEVER THERE WAS A LARGE AMOUNT OF GRANULATION TISSUE STILL PRESENT CIRCUMFERENTIALLY AROUND THE IMPLANT. IMPLANT WAS REMOVED DUE TO INFECTION. THE SITE WAS GRAFTED TOGETHER WITH ORIGINAL IMPLANT PLACEMENT.

  Patient problems: Unspecified Infection

  MAUDE report 12843777 ↗
• MalfunctionOct 4, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE INTERNAL IMPLANT THREADS WERE DAMAGED DURING A CLINICAL PROCEDURE AND IS REQUESTING TOOL ITEM # 0493 TO RE THREAD. THE IMPLANT IS WELL SEATED AND INTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12567230 ↗
• InjuryApr 1, 2021Fracture; Fracture

  NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11603344 ↗
• InjuryApr 1, 2021Fracture; Fracture

  NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11603254 ↗
• InjuryMar 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS VERY LITTLE ENGAGEMENT OF BONE WITH NO STABILITY. IMPLANT REMOVED. PATIENT TO RETURN FOR ADDITIONAL APPOINTMENT. AS A RESULT OF THE EVENT NO INJURY TO THE PATIENT WAS REPORTED. TOOTH LOCATION # 9.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11518776 ↗
• InjuryNov 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN IMPLANT (TMT4B13) WAS UNABLE TO BE PLACED INTO OSTEOTOMY. IMPLANT DID NOT ACHIEVE PRIMARY STABILITY AND IT WAS REMOVED. SITE WAS BONE GRAFTED. TOOTH LOCATION 29.

  Patient problems: No Information

  MAUDE report 9365743 ↗