Trabecular Metal™ TMTB13Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00889024019010), received between Apr 24, 2020 and May 5, 2025 — classified as 15 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT AFTER IMPLANTS WERE PLACED THE PATIENT RESUMED HIGH-IMPACT PHYSICAL ACTIVITIES TOO SOON AFTER SURGERY, LEADING TO ACCIDENTAL TRAUMA TO THE IMPLANT AREA. THE REPEATED FORCE CAUSED EARLY IMPLANT LOOSENING AND FAILURE. PAIN WAS REPORTED AS A RESULT OF THE EVENT. PATIENT WILL RETURN TO COMPLETE THE PROCEDURE.

  Patient problems: Pain

  MAUDE report 21958905 ↗
• MalfunctionSep 23, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20277802 ↗
• InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH MOBILITY OF THE IMPLANT AT TOOTH SITE #10. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN & INFLAMMATION

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 20179796 ↗
• InjuryApr 22, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE IMPLANT FRACTURED AND WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19160389 ↗
• InjuryAug 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT NOTICED THAT THEIR IMPLANT AT TOOTH LOCATION #26 HAD BECOME MOBILE. THE PATIENT HAD AN X-RAY TAKEN AT THE GENERAL DENTIST OFFICE AND THEN WAS SENT TO US FOR EXAMINATION OF THE IMPLANT. THE DOCTOR EXAMINED THE IMPLANT THROUGH A FLAP AND DEBRIDEMENT APPOINTMENT AND NOTED THE IMPLANT NEEDED TO BE REMOVED DUE TO THE AMOUNT OF BONE LOSS AND INSTABILITY.

  Patient problems: Osteolysis

  MAUDE report 17603494 ↗
• InjuryJul 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICIAN STATED #7 IMPLANT HAD RADIOLUCENCY IN PA AND A FISTULA 5MM POCKETING. NOTED ABSCESS.

  Patient problems: Unspecified Infection

  MAUDE report 17279838 ↗
• InjuryFeb 23, 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: Abscess; Osteolysis; Pain; Unspecified Infection

  MAUDE report 16427998 ↗
• InjuryDec 14, 2022Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO A FRACTURE OAT THE IMPLANT SITE.

  Patient problems: Pain

  MAUDE report 15977457 ↗
• MalfunctionApr 20, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THERE WAS NO IMPLANT INSIDE OF THE IMPLANT VIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14161991 ↗
• InjuryDec 3, 2021Adverse 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 A LACK OF PRIMARY STABILITY. THE BONE WAS TOO SPONGY TO KEEP IMPLANT IN. TOOTH # 25.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12924653 ↗
• InjuryJul 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A LACK OF PRIMARY. IMPLANT LOSS OF STABILITY DURING PLACEMENT. NEW IMPLANT WILL BE PLACED IN 2 MONTHS. TOOTH SITE # 6.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12206649 ↗
• InjuryJul 1, 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 12100842 ↗
• InjuryMar 18, 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: Pain

  MAUDE report 11517446 ↗
• InjuryOct 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT LACKED TORQUE DURING SURGERY AND WAS REMOVED. A NEW IMPLANT WAS PLACED AFTER 3 MONTHS.

  Patient problems: No Information

  MAUDE report 10716885 ↗
• InjuryJul 13, 2020Adverse 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 INFECTION.

  Patient problems: Inflammation; Pain; Swelling; Unspecified Infection

  MAUDE report 10265259 ↗
• InjuryJul 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 10 DUE TO PERI-IMPLANTITIS, BONE LOSS& INFECTION AT THE IMPLANT SITE AND WAS REMOVED. PT WAS SEEN ON (B)(6) 2020 TO UNCOVER AND TORQUE. THE PT HAD BEEN COMPLAINING OF PAIN AROUND IMPLANT. DURING UNCOVERING, THE DOCTOR NOTICED BONE LOSS AND INFECTION. IMPLANT WAS REMOVED AND BONE GRAFT AND MEMBRANE WAS PLACED. WILL LET HEAL FOR 4-6 MONTHS BEFORE REPLACING.

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 10264254 ↗
• InjuryApr 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN IMPLANT WAS UNABLE TO BE PLACED INTO OSTEOTOMY. IMPLANT (TMTB13) WAS SPINNING AND DID NOT ACHIEVE PRIMARY STABILITY AND IT WAS REMOVED. DOCTOR TRIED A LARGER IMPLANT AND IT DID NOT ACHIEVE STABILITY. SECOND IMPLANT WAS ALSO REMOVED. TOOTH LOCATION 4. SITE WAS BONE GRAFTED.

  Patient problems: No Information

  MAUDE report 9995545 ↗