ATTUNE 1504-10-103Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10603295041603), received between Feb 23, 2016 and Apr 8, 2026 — classified as 30 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 33 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT REVISED DUE TO SURGEON SUSPICION OF INSTABILITY. AFFECTED SIDE: LEFT.

  Patient problems: Joint Laxity

  MAUDE report 24815680 ↗
• MalfunctionMar 24, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE IMPLANT PACKAGING DURING A KNEE SURGERY. WHEN THE SURGEON OPENED THE FINAL STERILE IMPLANT BOX, THE BOX GOT STUCK TO THE BASE AND THE WRAPPER CAME OUT, LEAVING THE IMPLANT BEHIND IN THE BOX. THERE WAS NO SURGICAL DELAY OR PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21680144 ↗
• InjuryJan 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS AN INFECTION. IMPLANTS WERE REMOVED AND REPLACED WITH IMPLANT SPACER. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21199688 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECT SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 17170291 ↗
• InjuryJan 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS PRESENTED WITH KNEE INFECTION. DEPUY BONE CEMENT WAS USED. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6), 2019. DOR: (B)(6), 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16156777 ↗
• InjuryAug 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. THE SURGEON DECIDED IT BEST TO REMOVE ALL IMPLANTS AND PLACE A SURESPACE SPACER WITH ANTIBIOTIC CEMENT. ALL COMPONENTS WERE REMOVED. CEMENT MANUFACTURER WAS UNKNOWN. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15289694 ↗
• MalfunctionJan 4, 2022Tear, 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

  INNER PACKAGING DAMAGED AND OPEN WHILE THE OUTER PACKAGING IS SEALED. SURGICAL DELAY OF 3 MINUTES OCCURRED.

  Patient problems: Insufficient Information

  MAUDE report 13153589 ↗
• MalfunctionDec 17, 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

  IT WAS REPORTED THAT THE DISTRIBUTOR REPORTED THAT THE FEMORAL IMPLANT WHICH IS SUPPOSEDLY FOR THE PATIENT TODAY IS DEFECTIVE. THE BOX OUTSIDE SEAL IS INTACT WHEN OPENED, BUT THE ITEM ITSELF IS PARTLY OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13025357 ↗
• InjuryOct 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A LEFT ATTUNE TOTAL KNEE TO TREAT ARTHRITIS. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 2 WAS UTILIZED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. PATIENT RECEIVED A LEFT KNEE REVISION TO ADDRESS PAIN, FALL, SWELLING, INSTABILITY, SCAR TISSUE, OSTEOPHYTES, AND TIBIAL TRAY LOOSENING AT AN UNKNOWN INTERFACE. PREVIOUS PLATE AND SCREWS IMPLANTED DUE TO PRIOR DISTAL FEMORAL BONE FRACTURE WERE REMOVED BY A SECOND INCISION. THE PLATES AND SCREWS REMOVED WERE FROM AN UNKNOWN MANUFACTURER. THE SURGEON SUSPECTED OSTEOMYELITIS AND SENT SAMPLES WITH NO RESULTS GIVEN. THE TIBIAL INSERT, TIBIAL TRAY, AND FEMORAL COMPONENT WERE REVISED. THE PATELLA COMPONENT WAS RETAINED. THE PATIENT WAS REVISED WITH DEPUY PRODUCTS AND CEMENT X 2. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2015. DOR: (B)(6) 2021. LEFT KNEE.

  Patient problems: Fall; Joint Laxity; Pain; Scar Tissue; Swelling/ Edema; Unspecified Infection

  MAUDE report 12682948 ↗
• InjuryOct 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PAINFUL LEFT KNEE AND DISTAL FEMORAL BONE FRACTURE THAT OCCURRED A YEAR PRIOR TO THE REVISION OPERATION. UNKNOWN MANUFACTURER PLATE AND SCREWS WERE IMPLANTED TO ADDRESS THE FRACTURE. DOI: UNKNOWN; DOR: UNKNOWN; LEFT KNEE.

  Patient problems: Limb Fracture; Pain

  MAUDE report 12656332 ↗
• InjurySep 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPASS CASE (B)(4) REPORT: THE PATIENT WAS REVISED DUE TO PAIN. THE PHYSICIAN REVISED FEMUR COMPONENTS TO CRS WITH STEM. DOI: (B)(6) 2017, DOR: (B)(6) 2021: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 12487182 ↗
• InjuryJul 22, 2021Use of Device Problem; Use of Device Problem

  PATIENT WAS REVISED TO TREAT INSTABILITY AND MAL ROTATION OF THE FEMORAL COMPONENTS. THE TIBIAL TRAY WAS LOOSE AND DEBONDED AT THE CEMENT TO IMPLANT INTERFACE AND WAS REVISED. THERE WAS A 45 MINUTE DELAY TO REMOVE THE IMPLANTS. DOI: UNK, DOR: (B)(6) 2021, UNK KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12215217 ↗
• InjuryMay 25, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2017: PATIENT UNDERWENT A LEFT KNEE REPLACEMENT FOR OSTEOARTHRITIS. TRUMATCH CUTTING GUIDES WERE USED. DEPUY CEMENT X2 AND PATELLA WAS RESURFACED. ON (B)(6) 2021: PATIENT UNDERWENT A REVISION FOR POSSIBLE MECHANICAL LOOSENING. INFECTION WORK UP WAS NEGATIVE DURING THE REVISION THE FEMORAL COMPONENT (LOOSENING INTERFACE NOT MENTIONED) AND TIBIAL COMPONENT (CEMENT HAD DEBONDED) WERE BOTH NOTED TO BE LOOSE. THE TIBIAL TRAY WAS REMOVED BY HAND. SYNOVITIS WAS FOUND AFTER ENTERING THE JOINT SPACE. THE TIBIAL BONE HAD A CENTRAL DEFECT AND THERE WERE DEFECTS ON THE MEDIAL AND FEMORAL CONDYLES. ATTUNE REVISION IMPLANTS WERE PLACED WITH COMPETITOR CEMENT. THE PATELLA WASN'T REVISED. THE PATIENT TOLERATED THE PROCEDURE WITH NO COMPLICATIONS. DOI: (B)(6) 2017; DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Synovitis

  MAUDE report 11873984 ↗
• InjuryApr 5, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PRIMARY SURGERY WAS PERFORMED VIA TKA . ON AN UNKNOWN DATE, THE PATIENT REPORTED PAIN AND THE REVISION SURGERY WAS PERFORMED DUE TO LOOSENING. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 11614077 ↗
• InjuryAug 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF FEMORAL IMPLANT. IT HAD BEEN IMPLANTED IN THE PRIMARY OPERATION IN A FLEXED POSITION LIMITING PATIENT'S ABILITY TO FULLY FLEX HER KNEE.

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available

  MAUDE report 10443193 ↗
• InjuryJul 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ANEMIA. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019, DATE OF EVENT (ONSET): (B)(6) 2019, (LEFT KNEE). TREATMENT: RECEIVED 1 UNIT PACKED RED BLOOD CELLS WHILE IN THE HOSPITAL; RESOLVED (B)(6) 2019.

  Patient problems: Anemia; No Code Available

  MAUDE report 10288550 ↗
• InjuryJun 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED LEFT PRIMARY ATTUNE TKA TO TREAT END-STAGE OSTEOARTHRITIS. THE PATELLA WAS RESURFACED, AND DEPUY CEMENT X 2 WAS UTILIZED. THE SURGEON NOTED THAT THE PATIENT HAD POSTEROLATERAL INSUFFICIENCY DUE TO AN OLD ACL INJURY AND THAT THE POPLITEUS TENDON WAS ABSENT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT RECEIVE A LEFT TOTAL REVISION TO TREAT PAIN AND INSTABILITY. UPON ENTERING THE JOINT, THE SURGEON CONFIRMED GROSS INSTABILITY OF THE LEFT KNEE. THE TIBIAL TRAY AND FEMORAL COMPONENT WERE WELL-FIXED BUT REVISED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE EXPLANTED TIBIAL INSERT. THE PATELLA WAS RETAINED. THE SURGEONS NOTE THE PATELLAR TENDON WAS THINNING AT THE TIBIAL TUBERCLE AND WAS REATTACHED WITH SUTURE. THE PATIENT RECEIVED COMPETITOR REVISION PRODUCTS UTILIZING COMPETITOR CEMENT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2015. DOR: (B)(6) 2016; LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10130017 ↗
• InjuryApr 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY OPERATIVE NOTES (B)(6) 2017 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REPLACEMENT DUE TO END STAGE OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X2 WAS UTILIZED. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. REVISION OPERATIVE NOTES (B)(6) 2018 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REVISION DUE TO LOOSE TIBIAL COMPONENT, SEVERE FEMORAL BONE DEFECT WITH FEMORAL BONE CYST, SYNOVITIS AND EFFUSION. DEPUY IMPLANTS AND CEMENT WAS UTILIZED AT THE REVISION SURGERY. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. DOI: (B)(6) 2017, DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Cyst(s); Edema; No Code Available

  MAUDE report 9991681 ↗
• InjuryFeb 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO PAIN, DISCOMFORT, STIFFNESS, DECREASED RANGE OF MOTION, AND ADHESIONS. THE SURGEON NOTED TIBIAL TRAY MISPOSITIONING WITH SLIGHT OVERHANG AS WELL AS LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE FEMORAL COMPONENT WAS LOOSE AT THE BONE TO CEMENT INTERFACE WITH SLIGHT BONE LOSS OF THE LATERAL FEMORAL CONDYLE. THE SURGEON REPORTED WEAR ON BOTH THE TIBIAL TRAY AND TIBIAL INSERT. THE PATELLA COMPONENT WAS WELL-FIXED AND RETAINED. DEPUY CEMENT WAS USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2016; DOR: (B)(6) 2019; LEFT KNEE.

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

  MAUDE report 9672056 ↗
• InjuryJan 24, 2020Use of Device Problem; Malposition of Device; Use of Device Problem; Malposition of Device

  ATTUNE FIXED BEARING PS KNEE WAS REMOVED DUE TO GROSS MAL ALIGNMENT. TIBIAL COMPONENT WAS WELL FIXED, FEMORAL COMPONENT WAS WELL FIXED. PATELLA WAS LEFT IN. NEW CUTS WERE MADE, AND A SIGMA REVISION WAS PUT IN.

  Patient problems: No Code Available

  MAUDE report 9628987 ↗
• InjuryJan 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY: DOTS. CLINICAL NOTIFICATION RECEIVED FOR LEFT KNEE REVISION TO ADDRESS ARTHROFIBROSIS DATE OF IMPLANTATION: (B)(6) 2018; DATE OF EVENT (ONSET): (B)(6) 2019; (LEFT KNEE). FEMUR AND TIBIAL INSERT COMPONENTS REVISED.

  Patient problems: Adhesion(s); No Code Available

  MAUDE report 9553926 ↗
• InjuryJan 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS INDICATE THE PATIENT UNDERWENT A SECOND REVISION OF THE LEFT KNEE SECONDARY TO PAIN AND SUSPECTED LOOSENING OF THE TIBIAL COMPONENT. INTRAOPERATIVELY, THE SURGEON NOTED FAIR AMOUNT OF SCAR TISSUE; THE FEMORAL AND PATELLAR COMPONENTS WAS WELL FIXED; AND CONFIRMED THE TIBIAL COMPONENT WAS LOOSE AT THE CEMENT TO IMPLANT INTERFACE. THE SURGEON REMOVED THE FEMORAL COMPONENT ALTHOUGH WELL-FIXED, DUE TO REVISING TO A NON-COMPATIBLE SYSTEM. THE PATELLA WAS RETAINED. THERE WERE NO INTRAOPERATIVE COMPLICATIONS. DOI: (B)(6) 2013, (TWO DEPUY CEMENT, TRAY, FEMUR). DOR: (B)(6) 2014, (TIBIAL INSERT). DOR: (B)(6) 2015, (LEFT KNEE).

  Patient problems: Adhesion(s); No Code Available; Pain

  MAUDE report 9540667 ↗
• InjuryDec 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS FLEXION CONTRACTURE. DOI: (B)(6) 2018; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: Adhesion(s); No Code Available

  MAUDE report 9520674 ↗
• InjuryDec 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO PAIN AND INSTABILITY. THE SURGEON NOTED REMOVAL OF ADHESIONS AND HETEROTOPIC BONE AROUND THE PATELLA. THE PATELLA COMPONENT WAS NOT REVISED. THE SURGEON ALSO NOTED SCLEROTIC SURFACES. COMPETITOR CEMENT WAS USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2016, DOR: (B)(6) 2018 LEFT KNEE.

  Patient problems: Adhesion(s); No Code Available; Pain

  MAUDE report 9475309 ↗
• InjuryDec 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME IN FOR A TIBIAL REVISION WITH THE ORIGINAL ATTUNE FIXED BEARING TIBIAL TRAY. WHEN THEY WENT IN, BOTH THE FEMUR AND TIBIAL TRAY WERE WELL FIXED. THEY REMOVED BOTH IMPLANTS IN SPITE OF THE DIFFICULTY REMOVING THEM AND REPLACED WITH A SIGMA TC3. WHEN THE TIBIA WAS REMOVED, THERE WAS LITTLE CEMENT ON IT. SURGEON SPENT 15 MINUTES USING OSTEOTOMES AND SAWS TO SEPARATE THE TRAY FROM THE KNEE. NO WAY IT WAS LOOSE. AT THE END OF THE CASE, THE SURGEON INDICATED THAT THE REASON FOR REVISION TURNED OUT TO BE FOR A STIFF AND PAINFUL KNEE. THERE WAS NOTHING WRONG WITH THE IMPLANTS. DOI: UNKNOWN, DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9419152 ↗