Trabecular Metal™ TMTWB11Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00889024019041), received between Oct 4, 2019 and Jul 27, 2026 — classified as 24 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  Patient developed Peri-implantitis at tooth site 30. X-ray taken to check implant and the implant was fractured at mesh center. Removed fractured pieces of implant and bone grafted. Inflammation pain and swelling reported as a result of the event.Patient has elected to not replace the implant at this time.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 50017174 ↗
• InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #15 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AND IT WAS REMOVED. THE PATIENT WILL RETURN TO COMPLETE THE PROCEDURE.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 25218079 ↗
• InjuryNov 3, 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 #43 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 23458762 ↗
• InjurySep 16, 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 #19 DEVELOPED PERIIMPLANTITIS. THE ATTACHED GINGIVA IS EDEMATOUS AND ERYTHEMATOUS WITH EXUDATE, A CBCT SCAN WAS TAKEN TO EVALUATE BONE LEVELS. THE PATIENT HAS TAKEN 2 ROUNDS OF AZITHROMYCIN AFTER IMPLANT PLACEMENT. IT APPEARS THAT PERI-IMPLANTITIS OR IMPLANT FAILURE MAY BE SETTING IN. THE ONLY WALL OF THE IMPLANT WHICH IS INTEGRATING IS THE LINGUAL ASPECT. THERE IS ABOUT 6MM OF BONE LOSS ON THE MESIAL AND DISTAL AND THE BUCCAL ASPECT HAS ONLY THE APICAL 1/3 INTEGRATED. THE PATIENT HAS TAKEN 2 ROUNDS OF AZITHROMYCIN AFTER IMPLANT PLACEMENT THE PATIENT HAD FINISHED HIS ANTIBIOTICS BUT IS PREPARING TO GO ON A VACATION. HE WAS GIVEN ANOTHER RX FOR CLINDAMYCIN 300MG X 21 TABS, 0 REFILLS TO SUSTAIN THE INFECTION AND A SECOND RX FOR A ZPACK. THE PATIENT WAS ALSO GIVEN AN RX FOR ULTRACET IN THE INSTANCE HE EXPERIENCED SEVERE PAIN. THE PATIENT WAS INSTRUCTED HE DID NOT HAVE TO FILL THE RX FOR A ZPACK AND THE ULTRACET, ONLY IF NEEDED. ADDITIONAL APPOINTMENT REQUIRED: YES, IMPLANT REMOVAL #19. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, EDEMA, INFLAMMATION, PAIN, AND SWELLING.

  Patient problems: Erosion; Osteolysis; Unspecified Infection

  MAUDE report 23065582 ↗
• InjurySep 16, 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 #19 DEVELOPED PERIIMPLANTITIS. THE ATTACHED GINGIVA IS EDEMATOUS AND ERYTHEMATOUS WITH EXUDATE. A CBCT SCAN WAS TAKEN TO EVALUATE BONE LEVELS. THE PATIENT HAS TAKEN 2 ROUNDS OF AZITHROMYCIN AFTER IMPLANT PLACEMENT. IT APPEARS THAT PERI-IMPLANTITIS OR IMPLANT FAILURE MAY BE SETTING IN, THE ONLY WALL OF THE IMPLANT WHICH IS INTEGRATING IS THE LINGUAL ASPECT. THERE IS ABOUT 6MM OF BONE LOSS ON THE MESIAL AND DISTAL AND THE BUCCAL ASPECT HAS ONLY THE APICAL 1/3 INTEGRATED. THE PATIENT HAD FINISHED HIS ANTIBIOTICS BUT IS PREPARING TO GO ON A VACATION. HE WAS GIVEN ANOTHER RX FOR CLINDAMYCIN 300MG X 21 TABS, 0 REFILLS TO SUSTAIN THE INFECTION AND A SECOND RX FOR A ZPACK. THE PATIENT WAS ALSO GIVEN AN RX FOR ULTRACET IN THE INSTANCE HE EXPERIENCED SEVERE PAIN. THE PATIENT WAS INSTRUCTED HE DID NOT HAVE TO FILL THE RX FOR A ZPACK AND THE ULTRACET, ONLY IF NEEDED. THE PATIENT HAS TAKEN 2 ROUNDS OF AZITHROMYCIN AFTER IMPLANT PLACEMENT ADDITIONAL APPOINTMENT REQUIRED: YES, IMPLANT REMOVAL #19 SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, EDEMA, INFLAMMATION, PAIN AND SWELLING.

  Patient problems: Erosion; Osteolysis; Unspecified Infection

  MAUDE report 23065039 ↗
• InjurySep 15, 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 #19 DEVELOPED PERIIMPLANTITIS. THE ATTACHED GINGIVA IS EDEMATOUS AND ERYTHEMATOUS WITH EXUDATE. A CBCT SCAN WAS TAKEN TO EVALUATE BONE LEVELS. THE PATIENT HAS TAKEN 2 ROUNDS OF AZITHROMYCIN AFTER IMPLANT PLACEMENT. IT APPEARS THAT PERI-IMPLANTITIS OR IMPLANT FAILURE MAY BE SETTING IN. THE ONLY WALL OF THE IMPLANT WHICH IS INTEGRATING IS THE LINGUAL ASPECT. THERE IS ABOUT 6MM OF BONE LOSS ON THE MESIAL AND DISTAL AND THE BUCCAL ASPECT HAS ONLY THE APICAL 1/3 INTEGRATED. THE PATIENT HAD FINISHED HIS ANTIBIOTICS BUT IS PREPARING TO GO ON A VACATION. HE WAS GIVEN ANOTHER RX FOR CLINDAMYCIN 300MG X 21 TABS, 0 REFILLS TO SUSTAIN THE INFECTION AND A SECOND RX FOR A ZPACK. THE PATIENT WAS ALSO GIVEN AN RX FOR ULTRACET IN THE INSTANCE HE EXPERIENCED SEVERE PAIN. THE PATIENT WAS INSTRUCTED HE DID NOT HAVE TO FILL THE RX FOR A ZPACK AND THE ULTRACET, ONLY IF NEEDED. ADDITIONAL APPOINTMENT REQUIRED: YES, IMPLANT REMOVAL #19. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, EDEMA, INFLAMMATION, PAIN, AND SWELLING.

  Patient problems: Erosion; Osteolysis; Unspecified Infection

  MAUDE report 23057402 ↗
• InjurySep 15, 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 #19 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, EDEMA, INFLAMMATION, PAIN AND SWELLING.

  Patient problems: Erosion; Osteolysis; Unspecified Infection

  MAUDE report 23057020 ↗
• InjuryJul 28, 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 POSITION NUMBER #35 FAILED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22627046 ↗
• InjuryMar 12, 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 #30 WAS REMOVED DUE TO PERI-IMPLANTITIS SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION & PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 21584768 ↗
• InjuryAug 22, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20034330 ↗
• InjuryJun 27, 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 PERI-IMPLANTITIS. PATIENT WOULD HAVE TO RETURN TO PLACE A NEW IMPLANT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19621717 ↗
• InjuryMar 5, 2024Adverse 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: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 18841046 ↗
• InjuryJan 10, 2024Adverse 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: Osteolysis; Unspecified Infection

  MAUDE report 18483054 ↗
• InjuryNov 30, 2023Adverse 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. UNKNOWN TOOTH NUMBER.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 18240913 ↗
• InjuryNov 22, 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. TOOTH SITE # 28.

  Patient problems: Osteolysis

  MAUDE report 15848084 ↗
• InjuryNov 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12832527 ↗
• InjuryJul 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.

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

  MAUDE report 12246416 ↗
• InjuryJun 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR INDICATED LACK OF PRIMARY STABILITY. TOOTH SITE # 46 (FDI).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12063609 ↗
• InjuryMay 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11851546 ↗
• InjuryAug 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY CLINICIAN THAT IMPLANT SITE WAS PREPPED BUT IMPLANT DID NOT ACHIEVE PRIMARY STABILITY AT SITE # 20. IMPLANT REMOVED SITE GRAFTED. PATIENT TO RETURN IN 3 MONTHS FOR IMPLANT RE PLACEMENT. PATIENT'S CONDITION AT THE TIME OF EVENT: GOOD. AS A RESULT OF THE EVENT NO INJURY TO THE PATIENT WAS REPORTED. SYMPTOMS AS A RESULT OF THE EVENT: DELAYED HEALING.

  Patient problems: No Information

  MAUDE report 10442044 ↗
• InjuryJul 6, 2020Fracture; Fracture

  IT WAS REPORTED THAT THERE WAS A FAILURE AT #19 STRUCTURAL FAILURE POSSIBLE FRACTURE. #19 HAS BEEN DETERMINED TO BE FULLY INTEGRATED AND THERE IS NO MOBILITY. BONE LOSS AT THE TRABECULAR METAL AND AT THE CREST WAS NO POCKETING. PATIENT HYGIENE IS GOOD. BONE GRAFT DONE PRIOR TO THE PLACEMENT WITH ALLOGRAFT. PATIENT IS SCHEDULED TO HAVE THE IMPLANT REMOVED NEXT WEEK.

  Patient problems: No Information

  MAUDE report 10233760 ↗
• InjuryDec 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED THE PATIENT'S BONE WAS TOO SOFT AND COULD NOT ACHIEVE GOOD PRIMARY STABILITY WITH IMPLANT TMTWB11.

  Patient problems: No Information

  MAUDE report 9491033 ↗
• InjuryNov 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN IMPLANT (TMTWB11) WAS UNABLE TO BE PLACED INTO OSTEOTOMY. IMPLANT DID NOT ACHIEVE PRIMARY STABILITY AND IT WAS REMOVED. SITE WAS BONE GRAFTED. TOOTH LOCATION 3.

  Patient problems: No Information

  MAUDE report 9363354 ↗
• InjuryOct 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.

  Patient problems: No Information

  MAUDE report 9156974 ↗