Trabecular Metal™ TMTB10Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00889024018990), received between Nov 22, 2019 and Jul 31, 2025 — classified as 25 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (8 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 WAS REMOVED DUE TO BEING FRACTURED & PERI-IMPLANTITIS. PATIENT PRESENTED FOR RE EVALUATION ON (B)(6) 2025. SWOLLEN GUMS & PURULENT EXUDATE NOTED ON BUCCAL NEXT TO THE IMPLANT; OPENED FLAP, BONE LOSS ON BUCCAL 6MM. MOBILITY OF THE IMPLANT REMOVED BROKEN/FRACTURED PART OF THE IMPLANT. LEFT REMNANTS OF THE INTEGRATED PART OF THE IMPLANT & DISENGAGED APICAL PART OF THE IMPLANT DUE TO SINUS CAVITY INVOLVEMENT. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS & INFLAMMATION.

  Patient problems: Erosion; Osteolysis; Unspecified Infection

  MAUDE report 22678050 ↗
• InjuryJun 30, 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 #29 WAS REMOVED DUE TO PERI-IMPLANTITIS. THE BONE AROUND THE IMPLANT BECAME NECROTIC AND THE IMPLANT FAILED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22353039 ↗
• InjuryMar 18, 2025Fracture; Fracture

  IT WAS REPORTED AN IMPLANT FRACTURED. UPPER PART WAS REMOVED BUT LOWER PART OF THE IMPLANT WAS BURIED AND NEW IMPLANT WILL BE PLACE IN A DIFFERENT POSITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21633503 ↗
• InjuryJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PERI-IMPLANTITIS, PATIENT PRESENTED WITH LOOSE IMPLANT #10. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 19626382 ↗
• InjuryJun 3, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE 15 FRACTURED AT THE BODY OF THE IMPLANT AND WAS REMOVED. BONE LOSS WAS ALSO REPORTED. PAIN WAS REPORTED AS A RESULT OF THE EVENT. PROCEDURE WAS COMPLETED WITH OTHER IMPLANT.

  Patient problems: Osteolysis; Pain

  MAUDE report 19445554 ↗
• InjuryJun 3, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE 45 FRACTURED AT THE BODY OF THE IMPLANT AND WAS REMOVED. PROCEDURE WAS NOT COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19445516 ↗
• InjuryOct 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD STILL A DRAINING FISTULA AT IMPLANT TOOTH SITE #13, ASSOCIATED TO THE REPORTED INFECTION/ABSCESS. THEREFORE, THE PATIENT UNDERWENT LASER TREATMENT AND BONE GRAFT AROUND THE IMPLANT WHICH REMAINED IN PLACE.

  Patient problems: Unspecified Infection

  MAUDE report 17867816 ↗
• InjuryOct 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

  Patient problems: Unspecified Infection

  MAUDE report 17867725 ↗
• InjuryOct 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFECTION WAS REPORTED AND PATIENT WAS PLACED ON CLINDAMYCIN AGAIN. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN, INFLAMMATION.

  Patient problems: Unspecified Infection

  MAUDE report 17859369 ↗
• InjuryOct 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED PA AND OSSTELL READING OF THE IMPLANT AT TOOTH LOCATION #13 DUE TO INFECTION THAT NEVER RESOLVED AND WAS STILL DRAINING FISTULA. THE IMPLANT REMAINED IMPLANTED AND THE PATIENT WAS PLACED ON CLINDAMYCIN AND ANOTHER ANTIBIOTIC ARESTIN. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN, INFLAMMATION.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 17852196 ↗
• InjurySep 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED FISTULA WAS STILL PRESENT AROUND THE IMPLANT AT TOOTH LOCATION #13, THEREFORE THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN, INFLAMMATION.

  Patient problems: Fistula; Inflammation; Unspecified Infection

  MAUDE report 17843360 ↗
• InjurySep 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SEEN FOR EXCESSIVE SWELLING AND EXUDATE IN THE AREA OF THE IMPLANT AT TOOTH LOCATION #13. THE PATIENT WAS TREATED WITH CLINDAMYCIN AND THE IMPLANT REMAINED IMPLANTED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN, INFLAMMATION.

  Patient problems: Inflammation; Purulent Discharge; Unspecified Infection

  MAUDE report 17843215 ↗
• InjuryJul 21, 2023Fracture; Fracture

  CLINICIAN REPORTED CROWN LOOSENED. UPON VIEWING X-RAY A FRACTURED IMPLANT WAS FOUND. IMPLANT WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17373556 ↗
• InjuryJul 11, 2023Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17300183 ↗
• InjuryMay 22, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #29 LOST INTEGRATION AND WAS REMOVED DUE TO A FRACTURE. THE PATIENT CAME IN FOR A TORQUE TEST AND THE IMPLANT WAS BROKEN AND BURIED THE WHOLE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16974990 ↗
• InjuryJan 12, 2023Adverse 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: Inflammation; Pain; Unspecified Infection

  MAUDE report 16152550 ↗
• InjuryJan 12, 2023Adverse 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: Inflammation; Pain; Unspecified Infection

  MAUDE report 16152488 ↗
• InjuryNov 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INFECTION WAS NOTICED AT TOOTH SITE #31 DURING FOLLOW UP. CONTINUOUS PAIN WAS NOTED. THE PATIENT WILL RETURN FOR A FUTURE IMPLANT. SYMPTOMS: ABSCESS, PAIN AND INFLAMMATION.

  Patient problems: Abscess; Inflammation; Pain; Unspecified Infection

  MAUDE report 15733839 ↗
• InjuryOct 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT THE IMPLANTS AT TOOTH LOCATIONS #4 AND #12 WERE SHOWING SIGNS OF INFECTION AND WERE REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 15700827 ↗
• MalfunctionSep 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT FRACTURE DURING PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15335645 ↗
• InjuryAug 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #7 WAS REMOVED DUE TO MEDICAL INFECTION. ABSCESS AROUND APEX OF IMPLANT. ADDITIONAL APPOINTMENT REQUIRED: YES, TO REPLACE IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 15279198 ↗
• InjuryNov 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #13 WAS REMOVED DUE TO LACK OF PRIMARY STABILITY. THE IMPLANT ALMOST PERFORATED SINUS BUT DID NOT. THE IMPLANT WAS REMOVED AND THE SITE GRAFTED. ANOTHER IMPLANT WILL NOT BE PLACED IN THE SITE. THEY WILL DO A BRIDGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12802788 ↗
• MalfunctionOct 22, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 21 FRACTURED AT THE APEX DURING PLACEMENT. THE BROKEN PIECE WAS EVENTUALLY DISLODGED AND ANOTHER IMPLANT WAS PLACED ON THE SAME DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12681859 ↗
• InjuryAug 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPON FOLLOW UP WITH CUSTOMER, IT WAS CONFIRMED THAT THE PATIENT HAD INSUFFICIENT BONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12387781 ↗
• InjuryJul 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS THAT PATIENT PRESENTED IN OFFICE WITH PERI IMPLANTITIS AROUND THE TMTB10 IMPLANT IN TOOTH SITE #5. PAIN AND ABSCESS IS ALSO REPORTED. THE IMPLANT WAS REMOVED. THE SITE WAS GRAFTED PRIOR TO IMPLANT PLACEMENT WITH ALLOGRAFT.

  Patient problems: Abscess; No Code Available; Pain; Unspecified Infection

  MAUDE report 10258369 ↗