ATTUNE 1549-06-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10603295383079), received between Apr 26, 2019 and Apr 20, 2026 — classified as 43 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• InjuryApr 20, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN IN THE RIGHT KNEE WHEN WALKING AND REQUIRED REVISION SURGERY DUE TO LOOSENING OF IMPLANTS. THE REVISION PROCEDURE WAS PERFORMED TO ADDRESS PAIN AND IMPLANT LOOSENING AT AN UNKNOWN INTERFACE, AND ALL AFFECTED IMPLANTS WERE EXPLANTED AND DISCARDED. PATIENT HAD 3 PREVIOUS REVISIONS ON THIS KNEE.

  Patient problems: Pain

  MAUDE report 24927572 ↗
• InjuryNov 24, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT HAD A RIGHT TOTAL KNEE REVISION DONE BY THE DOCTOR AT THE HOSPITAL (B)(6) 2020. FEMUR BECAME LOOSE AND PATIENT WAS BROUGHT IN BY THE HOSPITAL FOR A FEMUR REVISION. FEMORAL COMPONENTS AND RP REVISION INSERT WERE REMOVED. THE RP REVISION TIBIA WAS NOT LOOSE AND STAYED IMPLANTED. NO COMPLICATIONS OR DELAYS IN SURGERY. DOI: (B)(6) 2020, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23633462 ↗
• InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN INITIAL SURGERY ON KNEE JOINT WITH ANOTHER COMPANY¿S PRODUCTS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO AN INFECTION WITH CEMENT MOLD. ON (B)(6) 2025 THE PATIENT UNDERWENT A DEBRIDEMENT DUE TO REINFECTION. ON (B)(6) 2025, THE PATIENT UNDERWENT COMPLETE REMOVAL AND MOLD REPLACEMENT WITH GENTAMICIN CEMENT FROM ANOTHER COMPANY AND FOUR TO SIX (4-6) WEEKS OF ANTIBIOTIC ADMINISTRATION IS PLANNED.

  Patient problems: Unspecified Infection

  MAUDE report 23607610 ↗
• InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN INITIAL SURGERY ON KNEE JOINT WITH ANOTHER COMPANY¿S PRODUCTS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO AN INFECTION WITH CEMENT MOLD. ON (B)(6) 2025 THE PATIENT UNDERWENT A DEBRIDEMENT DUE TO REINFECTION. ON (B)(6) 2025, THE PATIENT UNDERWENT COMPLETE REMOVAL AND MOLD REPLACEMENT WITH GENTAMICIN CEMENT FROM ANOTHER COMPANY AND FOUR TO SIX (4-6) WEEKS OF ANTIBIOTIC ADMINISTRATION IS PLANNED.

  Patient problems: Unspecified Infection

  MAUDE report 23607554 ↗
• InjurySep 10, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE SLEEVE, STEM, AND FEMUR AT THE CEMENT TO IMPLANT INTERFACE. REMOVED ALL FEMUR IMPLANTS AND DID NEW. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23016893 ↗
• InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION KNEE. THE PATIENT HAS HAD MILD PAIN SINCE THIS TIME. RECENT ASPIRATION WAS POSITIVE FOR INFECTION WHICH COULD HAVE BEEN PRESENT SINCE THE TIME OF REVISION. A ONE STAGE REVISION WAS PERFORMED AS THE ORGANISM IS SENSITIVE. ALL COMPONENTS WERE WELL FIXED AND WELL ALIGNED AND THE KNEE WAS WELL BALANCED. ALL COMPONENTS WERE REMOVED AND A THOROUGH DEBRIDEMENT WAS PERFORMED. NEW COMPONENTS, ALONG WITH PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS WERE PLACED IN A DUAL SET UP FASHION. NO DELAYS NOR PATIENT HARM WAS NOTED. SURGEON ROUTINELY UTILIZES DEPUY 2 WITH GENT FOR REVISION KNEE REPLACEMENTS. CEMENT IS HAND MIXED IN A BOWL. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 22772202 ↗
• MalfunctionJul 8, 2025Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE STERILE AUGMENT PACKAGING WAS NOT SEALED ON ONE END. THE PACKAGE WAS NOT BREACHED; IT WAS NEVER SEALED. THERE WAS NO DELAY IN THE CASE, NO BROKEN INSTRUMENTS, NO ADVERSE EVENTS. DOE: (B)(6) 2025, AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22440257 ↗
• InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD REVISION FOR INFECTION OF RIGHT REVISION TOTAL KNEE. THE KNEE WAS VERY INFECTED, AND ALL OF THE COMPONENTS CAME OUT WITH MINIMAL EFFORT. NO SPECIFIC COMPONENT WAS GROSSLY LOOSE. DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22105563 ↗
• InjuryApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2025 THAT THE PATIENT WAS REVISED DUE TO INFECTION. AN ARTICULATING SPACER AND ANTIBIOTICS WERE PLACED. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED AREA: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21763928 ↗
• InjuryApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2025 THAT THE PATIENT WAS REVISED DUE TO INFECTION. AN ARTICULATING SPACER AND ANTIBIOTICS WERE PLACED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED AREA: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21763367 ↗
• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6).STUDY NO: (B)(6). CLINICAL ADVERSE EVENTS RECEIVED FOR POSITIVE TISSUE BIOPSY X2 KNEE SYNOVIUM, DEVICE AND PROCEDURE(RELATEDNESS), DEVICE RELATED: DEFINITELY NOT, PROCEDURE RELATED: POSSIBLY, DATE OF EVENT: 15 JAN 2019, DATE OF IMPLANT: (B)(6) 2019, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: INJECTED MEDICATION.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 20507031 ↗
• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). STUDY NO: DSJ-2016-02. CLINICAL ADVERSE EVENTS RECEIVED FOR POSITIVE TISSUE BIOPSY X2 KNEE SYNOVIUM: DEVICE AND PROCEDURE (RELATEDNESS): DEVICE RELATED: DEFINITELY NOT. PROCEDURE RELATED: POSSIBLY. DATE OF EVENT: 15 JAN 2019. DATE OF IMPLANT: (B)(6) 2019. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: INJECTED MEDICATION.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 20506906 ↗
• InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INFECTED KNEE. DOI: (B)(6) 2024. DOR: (B)(6)2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20352440 ↗
• InjurySep 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A RIGHT KNEE REVISION OCCURRED ON SEPTEMBER 18, 2024 DUE TO A FRACTURED FEMUR POST INITIAL SURGERY. THE ORIGINAL IMPLANT SURGERY WAS AN UNKNOWN DATE IN 2020. THERE WAS NO SURGICAL DELAY AND NO ADDITIONAL PATIENT CONSEQUENCES.

  Patient problems: Limb Fracture

  MAUDE report 20303388 ↗
• InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT'S RIGHT KNEE WAS REVISED DUE TO INFECTION. AN ATTUNE REV KNEE CONSTRUCT WAS IN. IT WAS REVISED WITH A SINGLE STAGE REIMPLANT. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20145103 ↗
• InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT'S RIGHT KNEE WAS REVISED DUE TO INFECTION. AN ATTUNE REV KNEE CONSTRUCT WAS IN. IT WAS REVISED WITH A SINGLE STAGE REIMPLANT. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20145096 ↗
• InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY AFTER THE PATELLA TENDON RUPTURE. NO DELAY PATELLA IS AN IMPLANT AND NOT REMOVED. INSTABILITY NOT RELATED TO POLY WEAR DOI: (B)(6) 2024; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 18981177 ↗
• InjuryMar 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: 1. THE PATIENT FELL AND NEEDED LARGER COMPONENTS. 2. NO REPORTED SURGICAL DELAYS.

  Patient problems: Fall; Pain

  MAUDE report 18893616 ↗
• InjuryMar 5, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR FEMORAL LOOSENING OF THE STUDY KNEE. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: ON (B)(6) 2019, DATE OF REVISION: ON (B)(6) 2023, DATE OF EVENT: 30 AUG 2023, (LEFT KNEE). TREATMENT: REVISION; FEMORAL COMPONENT, FEMORAL SLEEVE, FEMORAL DISTAL AUGMENT, FEMORAL POSTERIOR AUGMENT, AND TIBIAL INSERT WERE REVISED.

  Patient problems: Insufficient Information

  MAUDE report 18835916 ↗
• InjuryMar 5, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR FEMORAL LOOSENING OF THE STUDY KNEE. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2019. DATE OF REVISION: (B)(6) 2023. DATE OF EVENT: 30 AUG 2023. (LEFT KNEE) TREATMENT: REVISION; FEMORAL COMPONENT, FEMORAL SLEEVE, FEMORAL DISTAL AUGMENT, FEMORAL POSTERIOR AUGMENT, AND TIBIAL INSERT WERE REVISED.

  Patient problems: Insufficient Information

  MAUDE report 18835914 ↗
• InjuryDec 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A REVISION KNEE REPLACEMENT IN 2022 DUE TO INFECTION. THE PATIENT PRESENTED TO THE CLINIC AGAIN IN FALL 2023. A FURTHER REVISION DUE TO AN INFECTION IS PLANNED FOR (B)(6) 2024. A SEPARATE COMPLAINT FOR THE FIRST REVISION WAS FILED UNDER (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18414072 ↗
• InjuryDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED WITH AN INFECTED KNEE POST REVISION TOTAL KNEE ARTHROPLASTY. ALL COMPONENTS WERE WELL ALIGNED, WELL FIXED AND APPROPRIATELY SIZED BUT WERE REMOVED DUE TO INFECTION. A ONE STAGE DUAL SET UP REVISION WAS PERFORMED WITH THOROUGH DEBRIDEMENT AND IRRIGATION AND PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. NO DELAY WAS ENCOUNTERED AND NO PATIENT HARM OCCURRED. THERE WERE TWO DATES OF IMPLANTATION AS THE PATELLAR COMPONENT WAS RETAINED FROM THE PRIMARY TOTAL KNEE ARTHROPLASTY ON (B)(6) 2022. ALL OTHER COMPONENTS LISTED WERE PLACED (B)(6) 2023. THE CEMENT UTILIZED WAS HOSPITAL INVENTORY AND AS SUCH WAS NOT AVAILABLE IN THE RECORDS. DOI: (B)(6) 2022(PATELLAR COMPONENT). DOI: (B)(6) 2023(ALL OTHER COMPONENTS). DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18301936 ↗
• InjuryDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED WITH AN INFECTED KNEE POST REVISION TOTAL KNEE ARTHROPLASTY. ALL COMPONENTS WERE WELL ALIGNED, WELL FIXED AND APPROPRIATELY SIZED BUT WERE REMOVED DUE TO INFECTION. A ONE STAGE DUAL SET UP REVISION WAS PERFORMED WITH THOROUGH DEBRIDEMENT AND IRRIGATION AND PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. NO DELAY WAS ENCOUNTERED AND NO PATIENT HARM OCCURRED. THERE WERE TWO DATES OF IMPLANTATION AS THE PATELLAR COMPONENT WAS RETAINED FROM THE PRIMARY TOTAL KNEE ARTHROPLASTY ON (B)(6) 2022. ALL OTHER COMPONENTS LISTED WERE PLACED (B)(6) 2023. THE CEMENT UTILIZED WAS HOSPITAL INVENTORY AND AS SUCH WAS NOT AVAILABLE IN THE RECORDS. DOI: (B)(6) 2022(PATELLAR COMPONENT). DOI: (B)(6) 2023(ALL OTHER COMPONENTS). DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18301789 ↗
• InjuryOct 18, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT PATIENT PRESENTED FOR REVISION OF UNI COMPARTMENTAL TO TOTAL KNEE ARTHROPLASTY. PRIOR TO IMPLANTATION OF IMPLANTS ALL IMPLANTS WHERE VERIFIED WITH OPERATING SURGEON, CIRCULATING NURSE AND SALES REPRESENTATIVE. IMPLANTS WHERE IMPLANTED AFTER BEING DELIVERED TO FIELD BY CIRCULATING NURSE. UPON INVESTIGATION OF REPRESENTATIVE BILLING SHEET, PRIOR TO PLACING TIBIAL INSERT, SALES REP DISCOVERED THAT THE FEMORAL IMPLANT WAS NOT FOR THE CORRECT SIDE. OPERATIVE SIDE AS (RIGHT) IMPLANT USED WAS (LEFT). SURGEON WAS NOTIFIED IMMEDIATELY, AND FEMORAL COMPONENT WAS SURGICALLY REMOVED. CORRECT IMPLANTS WHERE THEN PRESENTED TO THE SURGICAL FIELD AND IMPLANTED AT THIS TIME. THERE WAS NO HARM TO PATIENT. SURGICAL TIME WAS EXTENDED DUE TO REMOVAL OF FEMORAL IMPLANT. ALL EVENTS OCCURRED INTRAOPERATIVELY BEFORE PATIENT LEFT THE OPERATING ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17961175 ↗
• InjuryDec 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEFT ATTUNE REVISION REMOVAL DUE TO A POST OP FIXED FLEXION DEFORMITY FROM THE ORIGINAL REVISION SURGERY ON THE (B)(6) 2021 WITH A FOLLOWING SURGERY FOR A POLY REVISION ALSO DONE ON (B)(6) 2022 TO SEE IF WE DOWNSIZED THE POLY IF THAT WOULD HELP THE DEFORMITY. PATIENT WAS VERY UNHAPPY (ALSO NOT A COMPLIANT PATIENT WITH POST OP RECOVERY).

  Patient problems: Loss of Range of Motion

  MAUDE report 15994879 ↗