ATTUNE 1504-40-104Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10603295042174), received between Oct 11, 2019 and Mar 12, 2026 — classified as 21 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 25 reports, in the reporter's own words as published by the FDA.

• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. AND ALL COMPONENTS AND CEMENT WERE REMOVED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24581451 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED FOR INFECTION. SURGEON REMOVED PROSTHESIS PUT IN TEMPORARY SPACER. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24487266 ↗
• InjuryApr 22, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  SUBJECT ID: (B)(6), STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR LOOSENING OF COMPONENTS OF LEFT KNEE: DEVICE AND PROCEDURE (RELATEDNESS): DEVICE RELATED: POSSIBLY, PROCEDURE RELATED: POSSIBLY, DATE OF EVENT: 29-JAN-2025, DATE OF IMPLANT: (B)(6) 2020, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: LEFT. TREATMENT/IMPACT: NO INTERVENTION/TREATMENT AT THIS TIME. DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 150440104, LOT NUMBER ID: J3198U, COMPONENT TYPE: FEMORAL COMPONENT, DEVICE IDENTIFIER: (B)(4). CATALOG NUMBER: 151316110, LOT NUMBER ID: J2332W, COMPONENT TYPE: FEMORAL STEM, DEVICE IDENTIFIER: (B)(4). CATALOG NUMBER: 154904001, LOT NUMBER ID: J32A89, COMPONENT TYPE: FEMORAL MEDIAL POSTERIOR AUGMENT, DEVICE IDENTIFIER: (B)(4). CATALOG NUMBER: 154904002, LOT NUMBER ID: J4629Y, COMPONENT TYPE: FEMORAL LATERAL POSTERIOR AUGMENT, DEVICE IDENTIFIER: (B)(4). CATALOG NUMBER: 150660004, LOT NUMBER ID: 9113354, COMPONENT TYPE: TIBIAL BASE COMPONENT, DEVICE IDENTIFIER: (B)(4). CATALOG NUMBER: 151214030, LOT NUMBER ID: J5202D, COMPONENT TYPE: TIBIAL STEM, DEVICE IDENTIFIER: (B)(4). CATALOG NUMBER: 151302000, LOT NUMBER ID: 8596354, COMPONENT TYPE: FEMORAL STEM OFFSET AD

  Patient problems: Insufficient Information

  MAUDE report 21881585 ↗
• InjuryJan 23, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING FEMUR AND TIBIA. PATIENT APPEARED TO HAVE NOT ONLY LOOSE COMPONENTS BUT ALSO DISPLAYED METALOSIS ALL IN KNEE JOINT AND INTO THE BONE. IT APPEARED THIS CAME FROM THE JUNCTION B/N STEM AND FEMUR AND STEM AND TIBIA. BOTH STEMS SEEMED LOOSE AND DIDN'T APPEAR TO BE FULLY TIGHTENED DOWN UPON IMPLANTING. DOI: (B)(6) 2022. DOI: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Foreign Body Reaction

  MAUDE report 21217537 ↗
• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON FRACTURED LATERAL FEMORAL CONDYLE AFTER IMPACTING THE FEMORAL COMPONENT. SURGICAL DELAY UNKNOWN. DOE: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Limb Fracture

  MAUDE report 18185046 ↗
• MalfunctionOct 16, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PATELLAR CLUNK. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2010. DATE OF REVISION: (B)(6) 2020. DATE OF EVENT: (B)(6) 2023. (LEFT KNEE). TREATMENT: ARTHROSCOPY.

  Patient problems: Insufficient Information

  MAUDE report 17938733 ↗
• InjuryAug 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM DEPUY SYNTHES JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PRIMARY SURGERY WAS PERFORMED WITH THE IMPLANTS IN QUESTION. AFTER THE SURGERY, THE PATIENT FELL AND HAD A PERIPROSTHETIC FEMORAL IMPLANT FRACTURE. THE REVISION SURGERY IS SCHEDULED ON AN UNKNOWN DATE TO FIX THE AFFECTED AREA WITH PLATE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 17574918 ↗
• InjuryMar 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT HAS BEEN CREATED IN RELATION TO AEI NOTE A-(B)(4) UNDER (B)(4) TO REPORT AND EVENT POST LEFT KNEE REVISION ON (B)(6) 2022, PATIENT HAS A LEFT DVT IN THE LEFT DFV THAT IS TREATED WITH ORAL BLOOD THINNERS. DOI: (B)(6) 2022, DOR: UNKNOWN, LEFT KNEE SECOND COMPLAINT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16627390 ↗
• InjuryMar 10, 2023Adverse 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 THE SURGERY VIA THA WITH PFCS IMPLANTS IN QUESTION FOR LEFT KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, ASEPTIC LOOSENING OCCURRED ON AN UNKNOWN DATE. THEN, A REVISION SURGERY WAS DONE ON (B)(6) 2023. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY. AFTER THE REVISION SURGERY, THE PATIENT HAD INFECTION OF MRSA. THEN, ATTUNE REVISION PATELLA IMPLANT WAS REMOVED, AND CEMENT WITH ANTIBIOTICS HAS PLACED ON (B)(6) 2023. THIS TREATMENT WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16522104 ↗
• InjuryFeb 14, 2023Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT THE SURGERY VIA TKA. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THERE WAS THE POSSIBILITY OF METALLOSIS DUE TO MICRO-MOTION OF THE TAPER LOCK BETWEEN FEMORAL SLEEVE AND FEMORAL COMPONENT. THERE WAS ALSO THE POSSIBILITY OF LOOSENESS DUE TO METALOSIS. THE REVISION SURGERY WAS DONE ON AN UNKNOWN DATE. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE SURGEON COMMENTED THAT IT MIGHT BE A LOOSE TAPER LOCK. HE WANT THE INVESTIGATION TO IDENTIFY THE SOURCE OF THE METAL DEBRIS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body Reaction

  MAUDE report 16371303 ↗
• InjuryDec 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT NO EXTENSION TO SURGICAL TIME WAS REPORTED. NO DEPUY CEMENT IS LISTED IN THE PATIENT'S PRIMARY USAGE. ASSUMED TO BE COMPETITOR CEMENT AND THE AFFECTED SIDE OF THE PATIENT WAS THE LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16060027 ↗
• InjuryMay 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MOBILIZATION OF THE KNEE PROSTHESIS. REVISION OF THE LEFT KNEE PROSTHESIS AS PAINFUL AND RIGID.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 14419285 ↗
• MalfunctionMar 4, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THIS PATIENT HAD A LEFT TOTAL STRYKER KNEE THAT WAS BEING REVISED TO AN ATTUNE. THE TIBIA AND FEMUR WERE PREPPED PROPERLY WITH STEMS AND SLEEVES. ALL TRIAL CONSTRUCTS SAT PERFECTLY. THE REAL COMPONENTS WERE ASSEMBLED PROPERLY. THE REAL TIBIAL TRAY SAT 3MM PROUD. THE REAL FEMUR SAT 2MM PROUD. THIS CREATED AN IMBALANCE IN FLEXION VERSUS EXTENSION. THERE WAS A SURGICAL DELAY OF FIVE MINUTES. DOE: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13666216 ↗
• InjuryJul 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR POST-OPERATIVE ANEMIA. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2021, DATE OF EVENT: (B)(6) 2021, (LEFT KNEE). TREATMENT: BLOOD TRANSFUSION.

  Patient problems: Anemia

  MAUDE report 12234661 ↗
• InjuryJun 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR DEEP VENOUS THROMBOSIS. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020. DATE OF EVENT (ONSET): (B)(6) 2020. (LEFT KNEE). TREATMENT: ORAL MEDICATION (UNSPECIFIED).

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11971256 ↗
• InjuryJun 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PERSISTING PAIN. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS PROBABLY RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT (ONSET): (B)(6) 2020 (LEFT KNEE) TREATMENT: INJECTED AND ORAL MEDICATIONS (UNSPECIFIED), PHYSICAL THERAPY.

  Patient problems: Pain

  MAUDE report 11934165 ↗
• InjuryMar 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. REMOVED ALL COMPONENTS AND PUT IN A TEMPORARY ANTIBIOTIC KNEE SPACER. NO SURGICAL DELAY. DOI: (B)(6) 2019, DOR: (B)(6) 2021, LEFT KNEE.

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

  MAUDE report 11517290 ↗
• InjuryDec 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. THE CEMENT USED WAS FROM HOSPITAL'S INVENTORY SO, THERE WAS NO RECORD FOR THE LOT NUMBER. THE PATIENT UNDERWENT A POLY EXCHANGE ON (B)(6) 2020 (THIS WAS CAPTURED UNDER (B)(4)). NO LOOSENING AND SURGICAL DELAY NOTED. DOI: (B)(6) 2020, DOR: (B)(6) 2020 (POLY EXCHANGE), DOR: (B)(6) 2020, LEFT KNEE.

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

  MAUDE report 11078050 ↗
• InjurySep 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTED KNEE. REMOVAL OF IMPLANTS WAS PERFORMED. DOI: (B)(6) 2020. DOR: (B)(6) 2020. LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10507322 ↗
• InjuryJul 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED WITH INSTABILITY OF LATERAL LIGAMENTS. ON (B)(6) 2020, THESE REVISION IMPLANTS WERE REMOVED AND REPLACED WITH IMPLANTS FROM ANOTHER COMPANY. SIDE: LEFT.

  Patient problems: No Code Available

  MAUDE report 10242088 ↗
• MalfunctionJun 19, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE SURGEON OVER REAMED 1MM FOR THE FEMORAL STEM, AND BROACHED AND TRIALED APPROPRIATELY. THE REAL FEMORAL CONSTRUCT SAT PROUD AND WOULD NOT FULLY SEAT. IT SAT PROUD 3MM. DUE TO THIS, THE PATIENT HAS A GAP MISBALANCE, AND WILL NOT FULLY EXTEND. THE PRESSFIT FOR THIS CONSTRUCT IS TOO MUCH. UNLESS THE SURGEON PLANS TO BREAK FEMURS TO SEAT FULLY, IT IS VERY DIFFICULT IF NOT IMPOSSIBLE TO SEAT FULLY LIKE THE TRIAL CONSTRUCT SAT. A SURGICAL DELAY OF 20 SECONDS WAS NOTED. DOE: (B)(6) 2020.

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

  MAUDE report 10176537 ↗
• InjuryMar 17, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE DISLOCATION (DUE TO LIGAMENT LAXITY DUE TO SWELLING AND LYMPHEDEMA). EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT (ONSET): (B)(6) 2020. (LEFT KNEE). TREATMENT: CLOSED REDUCTION / MANIPULATION.

  Patient problems: Edema; Joint Dislocation; No Code Available

  MAUDE report 9843071 ↗
• InjuryMar 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR DEEP VENOUS THROMBOSIS. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND THERE IS A REMOTE POSSIBILITY IT IS RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018. DATE OF EVENT (ONSET): UNKNOWN ((B)(6) 2019) (LEFT KNEE). TREATMENT: INJECTED MEDICATION AND ORAL MEDICATION.

  Patient problems: No Code Available; Thrombosis

  MAUDE report 9811478 ↗
• InjuryFeb 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR DEEP VENOUS THROMBOSIS. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND THERE IS A REMOTE POSSIBILITY IT IS RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018; DATE OF EVENT (ONSET): (B)(6) 2019; (LEFT KNEE).

  Patient problems: No Code Available; Thrombosis

  MAUDE report 9741422 ↗
• MalfunctionOct 11, 2019Device-Device Incompatibility; Device-Device Incompatibility

  THIS COMPLAINT IS TO CAPTURE THE EVENT REPORTED IN (B)(4). IT WAS REPORTED THAT DURING IMPACTION OF THE FINAL FEMORAL IMPLANTS, THE FEMUR WOULD NOT SEAT FULLY. THE SURGEON CONTINUED WITH MODERATE TO HEAVY HITS TO SEAT THE FEMUR AND DECIDED TO LEAVE IT 2MM PROUD BECAUSE HE WAS AFRAID THE FEMUR WOULD BREAK. THE ANTERIOR FLANGE OF THE FEMUR GROUND AND SCRAPED ALONG THE ANTERIOR CORTEX AND WAS VERY CONCERNING THAT THIS WOULD CAUSE A FRACTURE. DOE: (B)(6) 2019. LEFT KNEE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9181061 ↗