ATTUNE 1520-20-606Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295542575), received between Apr 17, 2024 and Apr 30, 2026 — classified as 16 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (1 report).

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.

• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ PAIN/STIFFNESS. DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: (B)(6) 2026. DATE OF IMPLANT: (B)(6) 2025. DATE OF REVISION: (B)(6) 2026. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: COMPONENTS REMOVED (FEMORAL, INSERT, TIBIAL). DEPUY SYNTHES PRODUCTS USED. CATALOG NUMBER: 150401206. LOT NUMBER: 4035479. COMPONENT TYPE: FEMORAL. DESCRIPTION: ATTUNE CR FEM RT SZ 6 POR. CATALOG NUMBER: 150621006. LOT NUMBER: JA06A1468. COMPONENT TYPE: TIBIAL. DESCRIPTION: ATTUNE FB TIB BASE SZ 6 POR. CATALOG NUMBER: 152020606. LOT NUMBER: M5345X. COMPONENT TYPE: INSERT. DESCRIPTION: ATTUNE RIGHT MEDIAL STABILIZED INSERT SIZE 6 6MM. CATALOG NUMBER: 3322020. LOT NUMBER: 4513647. COMPONENT TYPE: CEMENT. DESCRIPTION: SMART SET BONE CEMENT 20G.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 25045118 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT I &D INSERT EXCHANGE. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 24747001 ↗
• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED WHERE THE POLY THICKNESS WAS INCREASED FROM 6 TO 8MM AND PATELLAS WAS RESURFACED. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 24420271 ↗
• InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DOCTOR EXPLANTED THE POLY BECAUSE THE PATIENT WAS UNSTABLE AND IMPLANT A THICKER POLY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24316200 ↗
• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE I&D POLY SWAP FOR INFECTION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24268472 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO POSSIBLE INFECTION. I&D WITH INSERT SWAP. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24078626 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT REVISED DUE TO TORN MEDIAL COLLATERAL LIGAMENT (MCL). DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23960052 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH STAGE 1 OF 2 REVISION. ANTIBIOTIC SPACER. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23879057 ↗
• InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD STABLE KNEE IN OR AFTER SURGERY. THE PATIENT GOT UP IN RECOVERY AND POPPED SOMETHING. THE PATIENT WAS BROUGHT BACK TO OR AND IT SEEMED THAT SHE LOST HER POSTERIOR CAPSULE. KNEE WAS EXPLANTED AND RP CRS WAS IMPLANTED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23476451 ↗
• MalfunctionSep 4, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT SURGEON WENT TO IMPACT THE 6X5MM MS POLY AND IT WASN¿T PROPERLY SEATING AND LOCKING INTO THE TRAY. SURGEON REMOVED THE 5MM INSERT, TRIED A 6X6MM MS POLY AND IT DID THE SAME THING. NOT PROPERLY SEATING AND LOCKING INTO THE TRAY. SURGEON HAD US OPEN A 6X7MM MS POLY AND THAT ONE SEATED PROPERLY. IT ADDED ABOUT 5 MINS TO TOTAL CASE TIME. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22965459 ↗
• InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTION OF THE KNEE. KNEE WAS WASHED OUT AND LINER WAS EXCHANGED. THERE WAS NO DELAY IN SURGERY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22674006 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SUSPECTED INFECTION. KNEE WAS WASHED OUT AND INSERT WAS EXCHANGED. THERE WAS NO DELAY IN SURGERY AND NO PATIENT INJURY. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22650510 ↗
• InjuryJul 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 INSTABILITY. INSTABILITY WAS NOT DUE TO POLY WEAR. PATIENT REPORTED FEELING A CHANGE AND PAIN AFTER DOING WEIGHTED LEG PRESSES IN PHYSICAL THERAPY. BOTH FEMUR AND TIBIA REQUIRED EXTENSIVE USE OF SAW AND OSTEOTOMES TO REMOVE. THERE WAS NO REPORTED MALPOSITION OF COMPONENTS THAT LED TO THE INSTABILITY. NO COMPONENTS WERE UNDERSIZED IN THE PRIMARY SURGERY. THE FEMUR OR TIBIA WERE NOT EXCESSIVELY RESECTED/HAD JOINT LINE RAISED DURING THE PRIMARY SURGERY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 22529394 ↗
• InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED WITH POLY EXCHANGE DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22331185 ↗
• InjuryJun 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED AS THE POLY LINER IS BEING EXCHANGED BECAUSE PATIENT IS UNABLE TO REACH FULL EXTENSION. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 22153698 ↗
• InjuryJun 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POLY WAS EXCHANGED BECAUSE PATIENT IS UNABLE TO REACH FULL EXTENSION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 22152873 ↗
• InjuryApr 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO LIMITED RANGE OF MOTION. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 19127553 ↗