ATTUNE 1504-00-208Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 10603295041238), received between Jan 5, 2018 and Sep 3, 2026 — classified as 43 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (9 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 25 most recent of 54 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2026Loss of or Failure to Bond

  It was reported the patient underwent a revision procedure due to poly wear and femoral loosening/collapse causing osteolysis.

  Patient problems: Osteolysis

  MAUDE report 50587863 ↗
• InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED FOR INSTABILITY. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE-RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 25002081 ↗
• MalfunctionMar 30, 2026Device Damaged Prior to Receipt by User

  ADDITIONAL EVENT INFORMATION: 1). PLEASE CONFIRM THAT THIS WAS AN INTRAOPERATIVE EVENT WITH A BRAND NEW FEMUR IMPLANT? YES. 2). WAS THE FEMUR IMPLANT ULTIMATELY USED, I.E IT REMAINED IMPLANTED? YES. 3). DID ANYTHING OCCUR DURING PREPARATION AND IMPLANTATION THAT MIGHT HAVE CONTRIBUTED TO THE DEFECTS OBSERVED ON THE FEMUR IMPLANT? NO. 4.) WAS THERE ANY ADVERSE CONSEQUENCE TO THE PATIENT RELEVANT TO THIS EVENT? KINDLY PROVIDE DETAILS. NOT KNOWN. 1. WAS THE FEMORAL COMPONENT FIRST REMOVED FROM THE STERILE PACKAGING IN THE OR? IMPLANT WAS JUST REMOVED BEVORE IMPLANTATEION. 2. PLEASE CLARIFY DID THE FEMORAL COMPONENT APPEAR IN THE SAME WAY AS WHAT IS SHOWN IN THE PHOTOS BELOW AT THE TIME IT WAS REMOVED FROM THE STERILE PACKAGING? IF YES, ARE THERE PHOTOS OF THE PRODUCT OUT OF THE BOX? YES. 3. WHAT WAS USED TO CLEAN/POLISH THE SURFACE OF THE FEMORAL COMPONENT BEFORE AND/OR AFTER IT WAS IMPLANTED? NACL. 4. WAS THE SURGERY COMPLETED WITH THE FEMORAL COMPONENT IMPLANTED AND WITHOUT CONSEQUENCE TO THE PATIENT? SURGERY WAS COMPLETE WITH THIS FEMUR IMPLANTED - CONSEQUENCE UNCLEAR.

  Patient problems: Insufficient Information

  MAUDE report 24729745 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION. DOI: (B)(6) 2025, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24393373 ↗
• InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE EXTRACTED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 23654059 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS PRESENTED WITH GROSS INFECTION WITH A DRAINING SINUS POST TKA. ALL COMPONENTS WERE REMOVED AND A THOROUGH I&D WAS PERFORMED AND A STATIC SPACER FASHIONED UTILIZING LPS COMPONENTS COATED WITH HIGH DOSE ANTIBIOTIC CEMENT. RESORBABLE ANTIBIOTIC BEADS WERE PLACED IN THE FEMORAL AND TIBIAL CANALS ALONG WITH THE GUTTERS. THERE WAS NO DELAY NOR WAS ANY PATENT HARM NOTED. DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 23301104 ↗
• InjurySep 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 INFECTION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23074784 ↗
• InjuryAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD FLEXION TIGHTNESS. SURGEON REMOVED THE FEMUR AND DOWNSIZED THE FEMUR. THERE WAS NO DELAY IN THE CASE. AND NO INSTABILITY. THERE WAS NO ISSUE WITH DEPUY IMPLANTS. SURGEON STATED HE OVERSIZED FEMUR. DOI: (B)(6) 2022, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 22741882 ↗
• MalfunctionJun 7, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT WHEN THE PACKAGE FOR A RIGHT FEMORAL CRUCIATE RETAINING SIZE 8 IMPLANT WAS OPENED, A HAIR WAS FOUND WITHIN THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22162877 ↗
• InjuryApr 4, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2020 INCLUDING PATELLA RESURFACING USING COMPETITOR CEMENT. THE PRIMARY OPERATION DID NOT HAVE ANY INTRAOPERATIVE ISSUES. ON (B)(6) 2023, THE PATIENT UNDERWENT A RIGHT KNEE REVISION FOR SYMPTOMS OF JOINT INSTABILITY, DIFFICULTY WALKING AND PAIN. INTRAOPERATIVELY THE SURGEON STATES BOTH FEMORAL AND TIBIAL COMPONENTS WERE LOOSE AT THE IMPLANT TO CEMENT INTERFACE. THE SURGEON DID REQUIRE AN IMPACTOR AND MALLET TO REMOVE BOTH COMPONENTS. THE TIBIAL TRAY HAD ALSO SUBSIDED MEDIALLY. AS THE SURGEON WAS REMOVING THE PATELLAR COMPONENT, HE NOTED THERE WAS HETEROTOPIC BONE LATERALLY THAT WAS REMOVED. DOI: (B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Pain

  MAUDE report 21775769 ↗
• MalfunctionMar 11, 2025Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE REPLACEMENT ON (B)(6) 2025. THE FEMORAL COMPONENT HAD SCUFF MARKS ON THE INSIDE SURFACE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21573854 ↗
• MalfunctionOct 10, 2024Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material; Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT WHEN THE NURSING TEAM TRIED TO OPEN ITEM DURING SURGERY, THE SCRUB NURSE WAS UNABLE TO TAKE THE STERILE INNER PACKAGING OUT OF THE UNSTERILE OUTER PACKAGING. THE SCRUB NURSE THEN REMOVED THE PAPER SEAL TO TAKE THE IMPLANT OUT. THE CIRCULATING NURSE AND SALES REPRESENTATIVE THEN ASSESSED THE PACKAGING AND COULD SEE THAT IT LOOKED LIKE THE TWO PLASTIC PACKAGES WERE MELTED AND HAD FUSED TOGETHER. THIS RAISED ISSUES ABOUT IMPLANT STERILITY. ONE OF THE NURSES ALSO NOTED THAT THE CIRCLE INDICATOR ON THE PAPER SEAL IS ORANGE, RATHER THAN RED AS WITH THE OTHER IMPLANTS. IT WAS ASSUMED THAT THE IMPLANT WAS NOT STERILE, SO A DIFFERENT IMPLANT WAS OPENED. THERE WAS A MINIMAL WAITING TIME AS THE SECOND IMPLANT WAS ON THEIR SHELF. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

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

  MAUDE report 20417498 ↗
• MalfunctionSep 6, 2024Difficult to Insert; Difficult to Insert

  DONE PROSTHETIC PAUSE IN ACCORDANCE TO THE GUIDE LINES,BUT FEMORAL IMPLANT APPEARED NOT TO FIT THE PREPARED DISTAL END OF THE FEMUR WHILE CEMENTING. CLEANED THE ARTICULAR SURFACE AND IMPLANT FOR ANY CEMENT RESIDUE AND RETRIED TO IMPACT BUT STILL WOULD NOT ENGAGE. RECHECKED ALL THE IMPLANTS STICKERS AND BOXES , RETRIED WITH THE TRAIL FEMUR AND STILL DID NOT ENGAGE. THE SURGEON MADE THE DECISION TO OPEN A SECOND FEMORAL COMPONENT, REPEATED THE PROSTHETIC PAUSE WITH THE TEAM AND TRAILED THE SECOND IMPLANT BEFORE CEMENTING AND THE CORRECT OUTCOME WAS ACHIEVED.

  Patient problems: Insufficient Information

  MAUDE report 20155403 ↗
• InjuryAug 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS CLINICAL ADVERSE EVENT RECEIVED FOR PATELLAR TENDON RUPTURE, EXTENSOR MECHANISM INSUFFICIENCY. DEVICE AND PROCEDURE (RELATEDNESS) REMOTE POSSIBILITY RELATED TO DEVICE, AND POSSIBLY RELATED TO PROCEDURE. DATE OF EVENT: (B)(6) 2024. DATE OF IMPLANT: INFORMATION NOT PROVIDED. DATE OF REVISION: INFORMATION NOT PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: REVISION ADDITIONAL EVENT INFORMATION: MEDICAL RECORDS (B)(4) CLINICAL NOTE AD ON (B)(6) 2024) REVIEWED: ON (B)(6) 2024, PATIENT WAS SEEN IN OFFICE FOR FOLLOW-UP VISIT. PATIENT PRESENTED WITH OBVIOUS COMPLETE PATELLA TENDON RUPTURE. PATIENT WAS HAVING HIS RIGHT KNEE GIVE OUT DAILY, WITH ONE INSTANCE OF ACTUALLY FALLING. RADIOGRAPHS SHOWED CLEAR PATELLA ALTA. PATIENT WILL BE SCHEDULED FOR A SURGICAL PATELLA TENDON REPAIR USING ALLOGRAFT.

  Patient problems: Unspecified Musculoskeletal problem; Unspecified Tissue Injury

  MAUDE report 20006183 ↗
• InjuryMay 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINS OF PAIN AND SURGEON NOTES GLOBAL INSTABILITY. ALL COMPONENTS ARE REMOVED AND A KNEE REVISION IS PERFORMED. NO DELAY OR PATIENT HARM IS NOTED. COMPONENTS ARE WELL FIXED, APPROPRIATELY SIZED IN GOOD ALIGNMENT AND JOINT LINE APPEARS APPROPRIATE. NO WEAR IS NOTED. DOI: (B)(6) 2022; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 19361364 ↗
• InjuryApr 30, 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 EVENT RECEIVED FOR EFFUSION IN RIGHT KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2013, DATE OF EVENT: (B)(6) 2014, (RIGHT KNEE). TREATMENT: CULTURE TAKEN.

  Patient problems: Swelling/ Edema

  MAUDE report 19215293 ↗
• MalfunctionSep 25, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT SMALL THREADS DISCOVERED INSIDE OF THE FEMORAL SHIELD. IT WAS DISCOVERED WHEN THE NURSE OPENED UP THE BOX AND THEY HAVE NOT TOUCHED THE PRODUCT. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17812471 ↗
• InjuryAug 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THE DECISION WAS MADE TO REMOVE ALL COMPONENTS AND REVISE HIS KNEE IN A ONE STAGE, DUAL SET UP REVISION WITH PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17563404 ↗
• InjuryJul 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF AN ATTUNE CR RP CONSTRUCT DONE DUE TO LOOSENING AND INFECTION. THE SURGEON SAID THAT THE PATIENT EXPERIENCED PAIN FROM EARLY ON AFTER THE SURGERY SO SAID THEY PROBABLY GOT THE INFECTION FROM THE START. IMPLANTS WERE LOOSE AT THE CEMENT/BONE INTERFACE. SIMPLEX CEMENT WAS USED. DOI: (B)(6) 2021. DOR: (B)(6) 2023. RIGHT KNEE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 17324506 ↗
• MalfunctionApr 13, 2023Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THE ATTUNE FEMORAL IMPLANT HAS SCRATCHES ON THE ARTICULAR SURFACE WITH WHITE TRANSLUCENT LINES RUNNING ACROSS THE CONDYLES. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16733405 ↗
• InjuryMar 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S PRIMARY KNEE WAS REVISED DUE TO INFECTION. DURING THE FIRST STAGE OF A PLANNED TWO STAGE REVISION PROCEDURE, ALL OF THE ATTUNE PRIMARY COMPONENTS WERE REMOVED. THE PATIENT'S KNEE WAS THEN THOROUGHLY IRRIGATED AND DEBRIDED. TEMPORARY SURESPACE ANTIBIOTIC SPACERS WERE THEN IMPLANTED. DOI: (B)(6), 2022. DOR: (B)(6), 2023. AFFECTED SIDE: RIGHT KNEE

  Patient problems: Unspecified Infection

  MAUDE report 16642688 ↗
• InjuryJan 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PARTIAL AVULSION PATELLAR TENDON/EXTENSOR MECHANISM INSUFFICIENCY. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2022. DATE OF EVENT: (B)(6) 2022. (RIGHT KNEE). TREATMENT: PROPHYLACTIC USE OF MITEK SUTURE TO SECURE AN INSIGNIFICANT PEEL OF THE MEDIAL THIRD OF THE PATELLAR TENDON INSERTION.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16146682 ↗
• InjuryMay 19, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  ATTUNE LOOSENING INFECTION. DOI: (B)(6) 2019; DOR: (B)(6) 2022; UNKNOWN SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 14435581 ↗
• InjuryApr 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTION. DATE OF IMPLANT: (B)(6) 2021 ; DATE OF REVISION: (B)(6) 2022 (RIGHT KNEE). REVISION OF FEMORAL, TIBIAL AND INSERT COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 14211963 ↗
• InjuryJan 6, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  MEDICAL RECORDS RECEIVED AD 07 DEC 2021. REVISION OPERATIVE NOTES (B)(6) 2021 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REVISION DUE TO PAIN, INSTABILITY, AND ASEPTIC LOOSENING. UPON ENTERING THE JOINT, SCARRING WAS NOTED TO BE RESECTED. THE FEMORAL COMPONENT WAS NOTED TO BE LOOSE, INTERFACE NOT PROVIDED. THE TIBIAL COMPONENT WAS ALSO NOTED TO BE LOOSE AT THE CEMENT TO IMPLANT INTERFACE. ALL COMPONENTS REVISED AND REPLACED WITH COMPETITOR PRODUCT. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. DOI: (B)(6) 2019; DOR: (B)(6) 2021: (RIGHT KNEE).

  Patient problems: Joint Laxity; Pain; Scar Tissue

  MAUDE report 13175480 ↗