ATTUNE 1506-70-008Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10603295492108), received between Mar 13, 2018 and Mar 4, 2026 — classified as 39 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (4 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Feb 22, 2021Class IITerminated

   Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be used in cemented applications.

   Z-1314-2021 · Root cause: Packaging change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED FOR PAIN AND ARTHROFIBROSIS. NO LOOSENING OF IMPLANTS AND NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Adhesion(s); Pain

  MAUDE report 24508236 ↗
• InjuryDec 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 23888099 ↗
• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23544885 ↗
• InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR INFECTION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23074938 ↗
• InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. AFFECTED SITE - LEFT KNEE.

  Patient problems: Pain

  MAUDE report 23053195 ↗
• InjurySep 11, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR ASEPTIC LOOSENING. TIBIAL COMPONENT WAS LOOSE AT CEMENT TO IMPLANT INTERFACE. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23027102 ↗
• InjuryAug 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION STAGE 1/2. NO DELAY. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22896033 ↗
• InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTION IN THE TOTAL KNEE. ALL IMPLANTS WERE REMOVED AND A STAGED ANTIBIOTIC SPACER WAS PLACED BY THE SURGEON. THERE WAS NO DELAYS IN SURGERY OR ANY PATIENT INJURY. DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22496796 ↗
• MalfunctionJun 19, 2025Device Markings/Labelling Problem; Wrong Label; Device Markings/Labelling Problem; Wrong Label

  IT WAS REPORTED THE YEAR OF REGISTRATION WAS INCORRECT ON THE LABEL OF THE IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22291967 ↗
• MalfunctionApr 29, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT INTRAOPERATIVELY IT WAS OBVIOUS THAT THE INNER STERILE COVER WAS GLUED WITH THE OUTER STERILE PACKAGE. THE IMPLANT NEEDED TO BE REMOVED WITH HELP OF A SCALPEL. NO SURGICAL DELAY, NO ADVERSE PATIENT CONSEQUENCES OCCURRED. SURGERY WAS COMPLETED WITHOUT ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21927380 ↗
• InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 18967646 ↗
• InjuryJan 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL, AND KNEE BECAME INFECTED. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2023 DOR- (B)(6) 2024 AFFECTED SIDE- RIGHT KNEE

  Patient problems: Fall; Unspecified Infection

  MAUDE report 18608873 ↗
• InjuryAug 24, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT COMPLAINING TO SURGEON OF 'CLICKING' IN RIGHT KNEE REPLACEMENT. THE SURGEON PERFORMED ARTHROSCOPY ON PATIENT'S RIGHT KNEE AND OBSERVED THE POLY INSERT TO BE LOOSE. CONVERTED TO OPEN PROCEDURE WHERE IT WAS DISCOVERED THE POLY INSERT WAS NOT ENGAGED IN THE TIBIAL TRAY AND WAS LOOSE. POLY INSERT REMOVED, DEBRIDEMENT AND WASHOUT PERFORMED AND NEW POLY INSERT OF SAME THICKNESS INSERTED (SIZE 8/5MM). DOI: (B)(6) 2023. DOE: (B)(6) 2023. AFFECTED SIDE: RIGHT.

  Patient problems: Insufficient Information

  MAUDE report 17611268 ↗
• InjuryApr 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 16808558 ↗
• InjuryMar 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMORAL COMPONENT AT THE BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. PATIENT COMPLAINED OF PAIN. BLOOD WORK INDICATED POSSIBLE INFECTION. PATIENT WAS SCHEDULED FOR A I&D WASH OUT AND POLY EXCHANGE. INTRAOP, THE FEMUR CAME OFF WITH NO FORCE. A CEMENT SPACER WITH ANTIBIOTIC¿S WAS IMPLANTED. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 16637458 ↗
• InjuryMar 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAIN. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 16512566 ↗
• InjuryFeb 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PATIENT STRUGGLING WITH LEFT KNEE PAIN. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2021, DATE OF EVENT: (B)(6) 2021. (LEFT KNEE) TREATMENT: PAIN MEDICATION.

  Patient problems: Pain

  MAUDE report 16372134 ↗
• InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO AN INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15815938 ↗
• InjuryOct 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION COMPLAINT RECEIVED AD (B)(6) 2022. PATIENT UNDERWENT BILATERAL KNEE REPLACEMENTS ON (B)(6) 2022. LEGAL CLAIM ALLEGES THE PATIENT SUFFERED FROM PAIN, DISABILITY, AND ADDITIONAL SURGERY. NO PRIMARY OR REVISION NOTES HAVE BEEN PROVIDED - ONLY THE PART/LOT INFORMATION FOR THE IMPLANTS PLACED. THIS PC CAPTURES THE RIGHT KNEE WHICH IS CAPTURED ON PAGES 3 AND 4. (B)(4) CAPTURES THE LEFT KNEE.

  Patient problems: Pain

  MAUDE report 15691130 ↗
• InjuryOct 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION COMPLAINT RECEIVED AD (B)(6) 2022. PATIENT UNDERWENT BILATERAL KNEE REPLACEMENTS ON (B)(6)2022. LEGAL CLAIM ALLEGES THE PATIENT SUFFERED FROM PAIN, DISABILITY, AND ADDITIONAL SURGERY. NO PRIMARY OR REVISION NOTES HAVE BEEN PROVIDED - ONLY THE PART/LOT INFORMATION FOR THE IMPLANTS PLACED. THIS PC CAPTURES THE LEFT KNEE WHICH IS CAPTURED ON PAGES 4 AND 5. (B)(4) CAPTURES THE RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 15690693 ↗
• InjuryApr 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INFECTION AS EVIDENCED BY LEFT KNEE PAIN, PATELLAR OSTEOLYTIC LESION, INCISIONAL ERYTHEMA, LEFT WOUND BUBBLING AND EFFUSION EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE EVENT IS NOT RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021. DATE OF EVENT (ONSET): (B)(6) 2022. (LEFT KNEE). TREATMENT: MEDICAL INTERVENTION (BACTRIM 2 WEEKS; DOSAGE & ROUTE OF ADMINISTRATION UNSPECIFIED), DIAGNOSTIC INTERVENTION (KNEE ASPIRATION/CULTURES).

  Patient problems: Erythema; No Clinical Signs, Symptoms or Conditions; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 13995793 ↗
• InjuryFeb 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT DEVELOPED AN INFECTION FOLLOWING TKA. KNEE WAS SWOLLEN AND PAINFUL. TESTING REVEALED JOINT WAS INFECTED. REVISION WAS COMPLETED WITH A DUAL SET UP UTILIZING ANTIBIOTIC CEMENT AND PLACEMENT OF ANTIBIOTIC RESORBABLE BEADS. DOI: (B)(6) 2021, DOR: FEB 10, 2022, LEFT KNEE.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 13592157 ↗
• InjuryFeb 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE PAIN, LEFT KNEE WOUND "BUBBLING", AND LEFT KNEE SWELLING/EFFUSION. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021; DATE OF EVENT (ONSET): (B)(6) 2022; (LEFT KNEE). TREATMENT: ASPIRATION AND BACTRIM X 2 WEEKS TO TREAT SWELLING/EFFUSION.

  Patient problems: Erythema; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 13479466 ↗
• InjuryJan 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED TOTAL KNEE. DOI: (B)(6) 2018, DOR: 2021, LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13168944 ↗
• InjuryDec 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD TIBIA REVISED FOR PAIN. NO ADDITIONAL INFORMATION. DOI:(B)(6) 2021. DOR: (B)(6) 2021. RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 13094208 ↗