Trabecular Metal™ TMTWB10Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00889024019034), received between Jul 3, 2020 and Feb 6, 2026 — classified as 29 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Component Missing” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2026Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24283213 ↗
• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #13 FAILED AND WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24193041 ↗
• InjuryNov 11, 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 INFECTION PT CAME IN FOR 1ST FOLLOW UP APPT & STATED AREA #30 IMPLANT WAS TENDER & INFLAMED THAT IT FELT LOOSE WHEN SHE PUT HER TONGUE OVER IN THE AREA. 2ND FOLLOW UP SHE HAD ABSCESS PRESENT & CAME BACK FOR IV SEDATION TO REMOVE ABSCESS & CLEAN IMPLANT AREA #30. NEXT FOLLOW UP SHE WAS SCHEDULED FOR IMPLANT REMOVAL SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN & INFLAMMATION.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 23523076 ↗
• InjuryOct 29, 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 #16 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 23416846 ↗
• InjuryNov 8, 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 #5 WAS REMOVED DUE TO INFECTION. PATIENT DEVELOPED INFECTION RESULTING IN IMPLANT REMOVAL. PER INDICATED: SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: NO. WAS THE PROCEDURE COMPLETED USING ANOTHER IMPLANT OR ANOTHER DEVICE: NONE INDICATED. ADDITIONAL APPOINTMENT REQUIRED: NO. SYMPTOMS AS A RESULT OF THE EVENT: PAIN & SWELLING.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 20641614 ↗
• InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER INDICATED: PERI-IMPLANTITIS. BONE LOSS. LOOSENING. THE PATIENT WAS RECEIVED 5 IMPLANT, PLACEMENT, 2 STAGED PROCEDURES. AFTER 8 MONTHS, THE PATIENTS CAME BACK FOR THE IMPRESSION PHRASE. SYMPTOMS AS A RESULT OF THE EVENT: NONE. SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: NO. ADDITIONAL APPOINTMENT REQUIRED: NO. WAS THE PROCEDURE COMPLETED USING ANOTHER IMPLANT OR ANOTHER DEVICE? NO.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20567076 ↗
• InjuryJul 15, 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 #13 WAS NOT STABLE AND HAD POSSIBLE INFECTION AND BEING A LITTLE MOBILE.

  Patient problems: Unspecified Infection

  MAUDE report 19745453 ↗
• InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES 16 AND 26 WERE REMOVED DUE TO PERI-IMPLANTITIS. PROCEDURE WAS NOT COMPLETED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19456817 ↗
• InjuryOct 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT LOST INTEGRATION DUE TO SINUS PERFORATION AND WAS REMOVED PER INDICATED: LOSS OF INTEGRATION, SINUS PERFORATION. ADDITIONAL APPOINTMENT REQUIRED TO PLACE A NEW IMPLANT. NONE SYMPTOMS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Sinus Perforation

  MAUDE report 17859792 ↗
• InjuryJun 15, 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: Osteolysis

  MAUDE report 17133330 ↗
• InjuryJun 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD COMPLAINED OF PAIN COMING FROM IMPLANT SITE AT TOOTH #19. DOCTOR EXAMINED THE IMPLANT SITE AND DISCOVERED INFECTION SURROUNDING THE IMPLANT. DOCTOR NOTED THAT THE IMPLANT WAS REMOVED, CLEANED OUT PREVIOUS IMPLANT SOCKET AND ALLOWED IT TO HEAL.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 17087782 ↗
• InjuryMay 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT THE IMPLANT FAILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16953502 ↗
• InjuryApr 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #18 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AT THE IMPLANT SITE AND WAS REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 16785793 ↗
• InjuryFeb 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED THAT THE PATIENT CAME COMPLAINING OF PAIN. XRAY TAKEN REVEALS PERIAPICAL LESION UNDER IMPLANT #18. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN.

  Patient problems: Abscess; Pain; Unspecified Infection

  MAUDE report 16292615 ↗
• InjuryJan 13, 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. PATIENT WOULD HAVE TO RETURN TO PLACE A NEW IMPLANT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 16155713 ↗
• InjuryJan 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BONE LOSS AROUND IMPLANT #30.

  Patient problems: Osteolysis

  MAUDE report 16110172 ↗
• InjuryDec 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #18 WAS REMOVED DUE TO INFECTION.SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 15915131 ↗
• MalfunctionAug 11, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THE CUSTOMER WENT TO OPEN AN IMPLANT PACKAGE FOR A CASE AND THE VIAL WAS EMPTY. WAS DISCOVERED WHEN THE ASSISTANT WENT TO OPEN THE IMPLANT FOR PLACEMENT. WHEN THEY OPENED THE VIAL, THERE WAS NO IMPLANT INSIDE. WE DID HAVE OTHER IMPLANTS IN STOCK SO WE WERE ABLE TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15210112 ↗
• MalfunctionJul 26, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THE IMPLANT WAS MISSING FROM THE PACKAGING. THE DOCTOR WAS IN SURGERY AND OPENED THE PACKAGING THAT WAS SEALED AND THE TUBE INSIDE THAT HAS THE IMPLANT IN IT WAS EMPTY. CUSTOMER CONFIRMED THAT THEY COMPLETED THE PROCEDURE WITH ANOTHER IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15105865 ↗
• InjuryJul 13, 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 #20 WAS REMOVED DUE TO MEDICAL INFECTION. PATIENT PRESENTS WITH SWELLING, TENDERNESS, REDNESS, AND SORENESS (DISCOMFORT). SYMPTOMS ALSO INCLUDE PAIN AND INFLAMMATION.

  Patient problems: Discomfort; Inflammation; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 15000009 ↗
• MalfunctionJan 12, 2022Separation Failure; Separation Failure

  IT WAS REPORTED THAT MOUNT DID NOT DISENGAGE FROM THE IMPLANT. THE PROCEDURE WAS FINISHED USING ANOTHER IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13234433 ↗
• InjuryOct 1, 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 # 30 (UNIVERSAL) WAS UNABLE TO BE PLACED DUE TO LACK OF PRIMARY STABILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12562061 ↗
• InjuryAug 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DOCTOR WAS UNABLE TO ACHIEVE PRIMARY STABILITY WITH THE IMPLANT AND THE IMPLANT WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12321348 ↗
• InjuryAug 11, 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 12310457 ↗
• InjuryJul 28, 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 12240620 ↗