ATTUNE 1506-80-007Recalls & reported problems

Summary

The FDA's MAUDE database contains 84 adverse event reports that list this exact device (DI 10603295492191), received between May 7, 2018 and Aug 6, 2026 — classified as 76 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (12 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 16, 2026.

Recalls naming this device

1. Feb 22, 2021Terminated

   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 84 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2026Loss of or Failure to Bond

  Patient problems: Pain

  MAUDE report 50162400 ↗
• InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50127435 ↗
• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT EXPERIENCED PAIN SO IT WAS DECIDED TO REMOVE EVERYTHING AND REPLACE WITH ATTUNE REVISION COMPONENTS. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 24413910 ↗
• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD DEVELOPED A CYST IN SOFT TISSUE MEDIAL AND POSTERIOR IN KNEE. COMMUNICATED WITH A CYST IN BONE. CYST WAS DRAINED AND TIBIA WAS REVISED. NO ALLEGATION AGAINST IMPLANTS; IMPLANTS WERE NOT LOOSE. DOI: (B)(6) 2020. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Cyst(s)

  MAUDE report 24367768 ↗
• InjuryDec 31, 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 INFECTION: THE ARTICULAR SURFACE OF THE MOBILE-BEARING POLYETHYLENE TIBIAL INSERT SHOWS MINOR YELLOWING".

  Patient problems: Unspecified Infection

  MAUDE report 23934712 ↗
• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: OASIS PROD. CLINICAL ADVERSE EVENT RECEIVED FOR INSTABILITY WITH DISLOCATED AND SPUN-OUT ROTATING PLATFORM LINER, IRREDUCIBLE. SIGNIFICANT INTRAOPERATIVE INBALANCE IDENTIFIED WITH POSTEROLATERAL INSTABILITY REQUIRING COMPLETE REVISION. PATELLAR COMPONENT RETAINED. DEVICE AND PROCEDURE (RELATEDNESS) DEVICE RELATED: PROBABLE PROCEDURE RELATED: PROBABLE DATE OF EVENT: 25 SEP 2025. DATE OF IMPLANT: (B)(6) 2025. DATE OF REVISION: (B)(6) 2025. DEVICE LOCATION: RIGHT TREATMENT/IMPACT: NONE/OBSERVATION: YES, COMPONENTS REMOVED: FEMORAL: YES TIBIA: YES, AND INSERT: YES.

  Patient problems: Joint Laxity

  MAUDE report 23555129 ↗
• InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN/INSTABILITY. DOI- UNKNOWN. DOR-(B)(6) 2025. AFFECTED SIDE- RIGHT SIDE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 23534852 ↗
• InjuryNov 4, 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 10 FOR Q3 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 DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 23463355 ↗
• InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 22689280 ↗
• InjuryJun 9, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO LOOSE TIBIA. TIBIA WAS LOOSE AT CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. DOI: (B)(6) 2022, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22169819 ↗
• InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FROM PRIMARY ATTUNE TO ATTUNE REVISION. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. DOI: (B)(6) 2021. DOR: (B)(6) 2025. AFFECTED AREA: RIGHT KNEE.

  Patient problems: Discomfort

  MAUDE report 22004264 ↗
• InjuryApr 1, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  THIS PATIENT WAS BEING REVISED TO DUE PAIN AND SUSPECTED LOOSE COMPONENTS AT CEMENT TO IMPLANT INTERFACE. DURING THIS CASE AN ATTUNE PS FEMORAL COMPONENT, RP TIBIAL BASEPLATE AND PS RP BEARING WERE REMOVED. THE PATELLA COMPONENT WAS LEFT IN PLACE. THE SURGEON PROCEEDED TO PREP AND IMPLANT ATTUNE REVISION COMPONENTS. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 21741443 ↗
• InjuryFeb 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS BEING REVISED DUE TO AN INFECTION. ALL PARTS WERE REMOVED AND A CEMENT SPACER WAS PLACED. DATE OF THE ORIGINAL PRIMARY SURGERY WAS UNKNOWN. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21440300 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON DETERMINED THAT THE PATIENT'S KNEE WAS NOT WELL BALANCED AND ELECTED TO DO TIBIA-ONLY REVISION. PRIMARY TIBIA AND INSERT WERE REMOVED AND REVISION TIBIA IMPLANTED. THERE WERE NO COMPLAINTS AND NO SURGICAL DELAYS. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21401880 ↗
• InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO ARTHROFIBROSIS. THERE WAS NO LOOSENING OF IMPLANTS. SURGICAL DELAY WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s)

  MAUDE report 21351223 ↗
• InjuryJan 28, 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 PAINFUL TOTAL KNEE ARTHROPLASTY (TKA). DOI: UNKNOWN AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 21258018 ↗
• InjuryJan 23, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THERE WAS A FAILED LEFT TOTAL KNEE ARTHROPLASTY AND THE TIBIAL COMPONENT WAS CLEARLY LOOSE. ON (B)(6) 2019, THE PATIENT UNDERWENT A LEFT TOTAL KNEE REVISION OF IMPLANTS BY AN UNKNOWN MANUFACTURER. ATTUNE REVISION IMPLANTS WERE PLACED AT THAT TIME WITH COMPETITOR CEMENT. ON (B)(6) 2023, THE PATIENT UNDERWENT A LEFT TOTAL KNEE REVISION DUE TO LOOSENING OF THE TIBIAL TRAY AT AN UNKNOWN INTERFACE. THE SURGEON MENTIONS THAT THE FEMUR AND TIBIA DID NEED TO BE REMOVED, THOUGH THERE ARE NO ALLEGATIONS AGAINST THE FEMORAL COMPONENT. THE SURGEON DECIDED TO REPLACE WITH A COMPETITOR PRODUCT. DOI:(B)(6) 2019 DOR: (B)(6) 2023 LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21219793 ↗
• MalfunctionNov 20, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO PATIENT CONSEQUENCE THAT AFFECTS THE PATIENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20734263 ↗
• InjuryOct 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPLANTED DUE TO INFECTION. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2022, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20532475 ↗
• InjuryJul 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PLANNED INLAY REVISION OF PS-ATTUNE-KNEE-TEP LEFT SIDE AFTER ABOUT ONE YEAR OF IMPLANTATION BECAUSE PATIENT HAD ISSUES STRETCHING THE KNEE. INTRAOPERATIVELY THE PE-INLAY SHOWED STRANGE SCRATCHES. SURGEON DECIDED TO CHANGE COMPLETE KNEE-TEP TO A COMPETITOR PRODUCT.

  Patient problems: Loss of Range of Motion

  MAUDE report 19836930 ↗
• InjuryJul 22, 2024Adverse 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 PAINFUL TOTAL KNEE. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 19794072 ↗
• InjuryJul 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAS A LONG HISTORY OF INFECTION. FEMUR, TIBIA, TIBIA POLY INSERT AND PATELLA WERE REMOVED BECAUSE OF INFECTION. TIBIA POLY WAS EXCHANGES (B)(6) 2023 BECAUSE OF INFECTION. DOI- (B)(6) 2023, DOR- (B)(6) 2024 , AFFECTED SIDE- RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 19782176 ↗
• InjuryJun 27, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIA AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CMV CEMENT WAS USED. UNKNOWN LOT NUMBER. THERE WERE NO SURGICAL DELAYS AND NO BROKEN INSTRUMENTS. DOI: (B)(6) 2023; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19624710 ↗
• InjuryJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR UNKNOWN PAIN. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. NO OTHER INFORMATION. DOI- (B)(6) 2022. DOR- (B)(6) 2024. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Pain

  MAUDE report 19564200 ↗
• InjuryApr 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED KNEE AND SEPTIC LOOSENING OF THE FEMUR AND TIBIAL COMPONENT AT THE BONE/CEMENT INTERFACE. DOI: (B)(6) 2023; DOR: (B)(6) 2024; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19106511 ↗