ATTUNE 1504-10-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295041672), received between Aug 7, 2017 and Mar 17, 2025 — classified as 11 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryMar 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 WITH BILATERAL RESECTIONS DUE TO INFECTIONS. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21619466 ↗
• InjuryJun 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTED JOINT. IMPLANTS WERE REMOVED, JOINT WAS WASHED OUT, I&D, CRS FEMUR AND RP CRS INSERT WERE IMPLANTED AS A SPACER. DOI: (B)(6) 2022, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17165199 ↗
• InjuryApr 11, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT HAD PRIMARY ATTUNE IMPLANTED APPROX 6 YEARS AGO AT ANOTHER HOSPITAL, UNABLE TO OBTAIN ACTUAL DATES. PRESENTED TO SURGEON'S CLINIC WITH PAIN IN HIS LEFT KNEE. CT SCAN AN X-RAY WERE TAKEN AND THIS SHOWED THAT THE IMPLANTS WERE LOOSE AND NEEDED TO BE REVISED.

  Patient problems: Inflammation; Pain

  MAUDE report 16712655 ↗
• MalfunctionMar 1, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  SCRUB TECH NOTICED FOAM FROM THE PACKAGING THAT STUCK TO THE FEMORAL COMPONENT. THE FOAM PIECES ARE FIXED TO THE IMPLANT AND WOULD NOT COME OFF. IMPLANT WAS REMOVED. SURGERY WAS ABLE TO CONTINUE AS PLANNED BECAUSE THEY HAD BACK UP IMPLANTS AVAILABLE. DOE: (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13637559 ↗
• MalfunctionNov 16, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT FOAM IN MANUFACTURING PACKAGE WAS STUCK TO CONDYLE SURFACE WHEN OPENED SO IMPLANT WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12823610 ↗
• MalfunctionNov 2, 2021Tear, 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

  DEFECTIVE IMPLANT - CAME IN STERILE PACKAGING WITH STYROFOAM MELTED ALL OVER THE FEMUR. IT WOULD NOT COME OFF OF THE METAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12737459 ↗
• MalfunctionNov 1, 2021Device Damaged Prior to Use; Device Contaminated During Manufacture or Shipping; Device Damaged Prior to Use; Device Contaminated During Manufacture or Shipping

  PATIENT DEMOGRAPHICS. DATE OF IMPLANTATION : (B)(6) 2021. DATE OF REVISION- N/A. OPERATIVE SIDE- LEFT. AGE AT THE TIME OF THE PROCEDURE-59, 44BMI, 6¿3, ACTIVITY LEVEL- UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12727608 ↗
• InjuryJul 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS WERE REVIEWED ON AD 26 MAY 2020 BY A CLINICIAN TO IDENTIFY PATIENT HARMS/PRODUCT ISSUES. PATIENT RECEIVED A LEFT PRIMARY ATTUNE TO TREAT SEVERE DEGENERATIVE OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND COMPETITOR CEMENT X 2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT RECEIVED A LEFT REVISION OF THE INSERT, FEMORAL COMPONENT, AND TIBIAL TRAY TO TREAT UNSPECIFIED MECHANICAL LOOSENING. THE PATELLA WAS RETAINED. REVISION OPERATIVE NOTES WERE NOT PROVIDED. DOI: (B)(6) 2015; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Adhesion(s); Hemorrhage/Blood Loss/Bleeding; No Code Available

  MAUDE report 10225866 ↗
• MalfunctionMay 19, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS WHAT APPEARS TO BE STYROFOAM FROM THE PACKAGING ADHERED TO THE SZ 10 ATTUNE PS LEFT FEMORAL COMPONENT. THE SURGEON REQUESTED ANOTHER IMPLANT. SOME OF THE DEBRIS WIPED OFF OF THE COMPONENT BUT THERE IS STILL RESIDUAL. THE COMPONENT WILL BE RETURNED. THERE WAS A SURGICAL DELAY OF 1 MIN. DOE: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 10073478 ↗
• InjuryDec 19, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2018, REVISED TO ADDRESS LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS, AND PAIN. THE SURGEON REPORTED A LOT OF ADHESION TISSUE AROUND THE PATELLA AND PATELLAR TENDON. HE INDICATED THE KNEE WAS VERY STIFFNESS. THERE WAS NO ADHERENCE AT THE FEMORAL - CEMENT TO IMPLANT INTERFACE. THE SURGEON INDICATED THE TIBIAL COMPONENT WAS COMPLETELY LOOSE AT THE COMPONENT TO CEMENT INTERFACE. HE NOTED THE PATELLA WAS FOUND TO BE PLACED LATERAL AND WITH SOME WEAR, AND REVISED. THE PATIENT WAS IMPLANTED WITH A COMPETITOR SYSTEM AND THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2015, (TIBIAL TRAY, CEMENT, PATELLA AND FEMORAL COMPONENT). DOI: (B)(6) 2016, (TIBIAL INSERT). DOR: (B)(6) 2018, (LEFT KNEE).

  Patient problems: Adhesion(s); Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 9497811 ↗
• InjuryDec 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS, AND PAIN. THE SURGEON REPORTED A LOT OF SCAR TISSUE AROUND THE PATELLA AND PATELLAR TENDON. HE INDICATED THE KNEE WAS VERY STIFF AND DIFFICULT TO FLEX UP. THE SURGEON REPORTED THE FEMORAL COMPONENT WAS FOUND TO BE VERY LOOSE AND TAMPED OFF WITH NO BONE LOSS. THERE WAS NO ADHERENCE AT THE FEMORAL COMPONENT TO CEMENT INTERFACE. THE SURGEON INDICATED THE TIBIAL COMPONENT WAS COMPLETELY LOOSE AT THE COMPONENT TO CEMENT INTERFACE. HE NOTED THE PATELLA WAS FOUND TO BE PLACED LATERAL AND WITH SOME WEAR, AND REVISED. THE PATIENT WAS IMPLANTED WITH A COMPETITOR SYSTEM AND THERE WERE NO COMPLICATIONS TO THE PROCEDURE.PRIMARY PRODUCT INFORMATION CAN BE FOUND ON PAGE 8/17 OF THE ATTACHED MEDICAL RECORDS. TWO DEPUY CEMENT PRODUCTS WERE USED DURING PRIMARY OPERATION. PLEASE ADD HOSPITAL ACCOUNT INFORMATION. AWARENESS DATE IS (B)(6) 2019.

  Patient problems: Adhesion(s); No Code Available

  MAUDE report 9497247 ↗
• InjuryOct 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED 17 JUNE 2019 AND WERE REVIEWED 07 OCTOBER 2019 FOR MDR REPORTABILITY. ON (B)(6) 2017, THE PATIENT UNDERWENT TOTAL LEFT KNEE ARTHROPLASTY DUE TO ARTHRITIS AND PAIN. THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH THE DEPUY KNEE SYSTEM AND COMPETITOR¿S BONE CEMENT. ON (B)(6) 2017, THE PATIENT UNDERWENT A STAGE 1 REVISION WITH A TEMPORARY KNEE SPACER AND MEDIAL GASTRIC FLAP RAISED INSET OVER SPACER, DUE TO INFECTION. ALL COMPONENTS WERE REMOVED, AND ANTIBIOTIC SPACER PLACED. THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2017; DOR: (B)(6) 2017; (LT KNEE).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9254920 ↗
• InjuryOct 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED 17 JUNE 2019 AND WERE REVIEWED 26 SEPTEMBER 2019 FOR MDR REPORTABILITY. ON (B)(6) 2016, THE PATIENT UNDERWENT TOTAL LEFT KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS. THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH THE ATTUNE KNEE SYSTEM AND SMARTSET BONE CEMENT X 2. ON (B)(6)2018, THE PATIENT UNDERWENT LEFT KNEE REVISION DUE TO INFECTION AND DISLOCATED POLYETHYLENE INSERT. THE SURGEON REPORTED ELEVATED CRP AND RATE 4.03 AND 43 RESPECTIVELY IN THE PREVIOUS MONTH. HE REPORTED CULTURE (B)(6) OF (B)(6). THE SURGEON ALSO NOTED CONSISTENT DRAINAGE THE 10 DAYS PRE-SURGERY. HE INDICATED PRIOR TO ENTERING THE KNEE, THE KNEE WAS ASPIRATED, AND GROSS PUSS WAS ENCOUNTERED AND SENT TO LAB. THERE WERE NO LAB RESULTS INCLUDED IN THE PATIENT¿S RECORDS. THE SURGEON REPORTED AN AGGRESSIVE SYNOVECTOMY WHERE THE TIBIAL INSERT WAS FOUND DISASSOCIATED FROM THE TIBIAL PLATE. HE REPORTED THE TIBIAL AND FEMORAL COMPONENTS WERE WELL-FIXED THOUGH REVISED. THE PATELLA WAS REVISED. THE PATIENT WAS IMPLANTED WITH A COMPETITOR SYSTEM AND THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2016. DOR: (B)(6) 2018 (LT KNEE).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9202683 ↗
• InjuryOct 10, 2018Loss of or Failure to Bond; Appropriate Device Problem Term/Code Not Available; Loss of or Failure to Bond; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL AND TIBIAL COMPONENT AT THE BONE TO CEMENT AND CEMENT TO IMPLANT INTERFACE.

  Patient problems: No Code Available; Pain

  MAUDE report 7951042 ↗
• InjuryAug 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT (B)(6). ASSOCIATED STUDY: (B)(6). CLINICAL NOTIFICATION RECEIVED FOR REVISION RELATED TO PAIN AND STIFFNESS. DOI: (B)(6) 2017. DOR: (B)(6) 2018 . (LEFT KNEE) PT UNDERWENT SECOND REVISION OF LEFT KNEE.

  Patient problems: Limited Mobility Of The Implanted Joint; Not Applicable; Pain

  MAUDE report 7822689 ↗
• InjuryAug 7, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6772272 ↗