ATTUNE 1506-80-006Recalls & reported problems

Summary

The FDA's MAUDE database contains 95 adverse event reports that list this exact device (DI 10603295492184), received between Jan 10, 2019 and Sep 29, 2026 — classified as 88 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (16 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-1316-2021 · Root cause: Packaging change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 95 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50935138 ↗
• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  Thayer School of Engineering at Dartmouth first report of retrievals for Statement of Work 10 for Q2 of 2026. Darthmouth is the research location, and not the facility of placement.A DePuy Synthes Implant was revised and reviewed for analysisReason for revision: Revision due to infection and stiffness.

  Patient problems: Muscular Rigidity; Unspecified Infection

  MAUDE report 50168062 ↗
• InjuryAug 6, 2026Loss of or Failure to Bond

  Patient problems: Pain

  MAUDE report 50158144 ↗
• InjuryAug 4, 2026Loss of or Failure to Bond

  It was reported that the patient was revised due to ligamentous instability and loosening of the tibia at the cement to implant interface. DePuy cement was used.Affected side-Left knee.

  Patient problems: Joint Laxity

  MAUDE report 50131746 ↗
• InjuryMay 28, 2026Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAVE ASEPTIC LOOSENING OF IMPLANTS. REMOVAL OF FEMORAL COMPONENT AND TIBIAL COMPONENT. TIBIA APPEARED LOOSE. DOI- (B)(6) 2022. DOR- (B)(6) 2026. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 25316377 ↗
• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SPACER WAS EXPLANTED FOR INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 24426777 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A PAINFUL KNEE. DOI: (B)(6) 2022. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 24326666 ↗
• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. LEFT TOTAL KNEE ARTHROPLASTY WAS DONE. DOI: (B)(6) 2021, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24221449 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SOFT TISSUE INFLAMMATION. THERE WAS LOOSENING OF FEMUR AND TIBIA AT BONE TO CEMENT INTERFACE. COMPONENTS REMOVED AND REVISION COMPONENTS REPLACED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24036695 ↗
• InjuryJan 5, 2026Loss of or Failure to Bond

  PATIENT HAD MULTIPLE EFFUSIONS. THERE WAS A LOOSENING OF TIBIA AT UNKNOWN INTERFACE. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Swelling/ Edema

  MAUDE report 23958604 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK FOR Q4 OF 2025. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION FOR PAIN. THE REVISED NON-ARTICULAR SURFACE OF THE MOBILE-BEARING POLYETHYLENE TIBIAL INSERT SHOWS SEVERE ABRASIVE WEAR. THE ARTICULAR SURFACE SHOWS MODERATE PITTING.

  Patient problems: Pain

  MAUDE report 23925868 ↗
• InjuryDec 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THERE IS INFECTION IN THE LEFT KNEE TOTAL PROTHESIS.

  Patient problems: Unspecified Infection

  MAUDE report 23908865 ↗
• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED. DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23547284 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q3 OF 2025. DARTMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS THE REASON FOR THE REVISION WAS DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 23469332 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q3 OF 2025. DARTHMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION DUE TO INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 23467978 ↗
• InjuryOct 21, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIA AT THE BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. TIBIA COLLAPSED. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23348722 ↗
• InjuryOct 20, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO TIBIAL LOOSENING. PRODUCT STATED TO BE LOOSE: TIBIA, LOOSENING INTERFACE: CEMENT TO IMPLANT, CEMENT MANUFACTURER: UNKNOWN. DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23343086 ↗
• InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A TOTAL KNEE IN 2022. CUSTOMER WAS NOT ABLE TO FIND THE EXACT DATE IN 2022 ON WHICH THE SURGERY WAS PERFORMED. PATIENT PRESENTED WITH INFECTED TOTAL KNEE. SURGEON REMOVED THE TOTAL KNEE AND REPLACED WITH ANTIBIOTIC IMPREGNATED SURE-SPACE CEMENT SPACER. PATELLA WAS LEFT IN PLACE. ALL AVAILABLE INFORMATION HAS BEEN FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED. DOI: (B)(6) 2022, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22924120 ↗
• InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22679845 ↗
• InjuryJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT A TKA SURGERY FOR OA ON KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY, IN (B)(6) 2025, THE PATIENT HAD PAIN AND AN INFECTION WAS DISCOVERED. THE REMOVAL SURGERY IS SCHEDULED ON (B)(6).

  Patient problems: Pain; Unspecified Infection

  MAUDE report 22395010 ↗
• InjuryApr 4, 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 GLOBAL INSTABILITY. THE LIGAMENTS ARE CHRONICALLY LOOSE. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21774449 ↗
• InjuryFeb 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND HAD A PROXIMAL TIBIA FRACTURE. DOCTOR WANTED TO REMOVE PRIMARY TIBIA COMPONENT AND REPLACE WITH A LONGER TIBIAL IMPLANT WITH STEM. DOCTOR ALSO PUT ON A STEP WEDGE ON LATERAL SIDE OF TIBIAL IMPLANT TO HELP WITH STABILIZATION FROM FRACTURE. SURGEON REPLACE THE POLY WITH THE APPROPRIATE SIZE FOR STABILITY. NO PROBLEMS WITH OUR IMPLANTS JUST A FRACTURE FROM THE FALL. DOI: (B)(6) 2021. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 21472291 ↗
• InjuryFeb 4, 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 FIBROSIS. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s)

  MAUDE report 21307461 ↗
• InjuryJan 23, 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 PAINFUL RIGHT KNEE. PATIENT HAD A SIGNIFICANT FLEXION CONTRACTURE. THE SURGEON OPTED FOR A FEMORAL TIBIAL REVISION TO BALANCE THE KNEE. DOI: UNKNOWN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Contracture; Pain

  MAUDE report 21222529 ↗
• InjuryDec 13, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE SURGEON BELIEVES HE EXTENDED THE KNEE PRIOR TO CEMENT HARDENING WHICH INDUCED ANTERIOR SLOPE INTO THE TIBIAL COMPONENT WHICH CAUSED LOOSENING OVER TIME.

  Patient problems: Insufficient Information

  MAUDE report 20930372 ↗