ATTUNE 1504-00-126Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10603295041153), received between Aug 8, 2018 and Sep 25, 2026 — classified as 30 injuries, 1 malfunction.

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

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 50901045 ↗
• InjuryJul 7, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PRIMARY ATTUNE FEMUR LOOSENED AT CEMENT TO IMPLANT INTERFACE AND NEEDED REVISED. DEPUY CEMENT WAS USED. AFFECTED SIDE : LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22411364 ↗
• InjuryMar 5, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS HAVING A DIFFICULT TIME GETTING FLEXION. THERE WAS CONCERN THAT THE FEMUR MAY BE LOOSE. REVISION WAS PERFORMED. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 21527258 ↗
• InjuryJan 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 DUE TO STIFFNESS. FEMUR TRAY AND POLY WERE ALL REVISED. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 21180843 ↗
• InjuryDec 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS. DATE OF EVENT: 8/NOV/2024. DEVICE LOCATION: LEFT. ON (B)(6) 2024, THE PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY TO ADDRESS LEFT KNEE ARTHRITIS. THE INDICATIONS FOR SURGERY INCLUDED A LARGE POSTEROLATERAL TIBIAL DEFECT AND MARKED VALGUS DEFORMITY WITH A HYPOPLASTIC LATERAL FEMORAL CONDYLE. DEPUY COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE, INCLUDING DEPUY PATELLA. CLINICAL ADVERSE EVENT RECEIVED FOR ACUTE DEEP VEIN. THROMBOSIS (DVT) OF LEFT LOWER EXTREMITY (PAIN, SEVERE). DEVICE RELATED: DEFINITELY NOT. PROCEDURE RELATED: PROBABLY. DATE OF IMPLANT: (B)(6) 2024. TREATMENT/IMPACT: READMITTED ON (B)(6) 2024.

  Patient problems: Pain; Thrombosis/Thrombus

  MAUDE report 21026249 ↗
• InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND REVIEWED BY A CLINICIAN; ON (B)(6) 2024 , THE PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY TO ADDRESS LEFT KNEE ARTHRITIS. THE INDICATIONS FOR SURGERY INCLUDED A LARGE POSTEROLATERAL TIBIAL DEFECT AND MARKED VALGUS DEFORMITY WITH A HYPOPLASTIC LATERAL FEMORAL CONDYLE. DEPUY COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE, INCLUDING DEPUY PATELLA. PAST MEDICAL DIAGNOSIS: DEPRESSION, HYPERTENSION, HYPOTHYROIDISM, MONOCLONAL GAMMOPATHY OF UNKNOWN SIGNIFICANCE, MALIGNANT NEOPLASM OF RIGHT BREAST.

  Patient problems: Pain; Thrombosis/Thrombus

  MAUDE report 20796102 ↗
• InjuryNov 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, PATIENT REPORTEDLY RECEIVED A LEFT TOTAL KNEE REVISION TO ADDRESS PAIN, FLEXION INSTABILITY, AND ASEPTIC LOOSENING OF THE TIBIAL BASEPLATE. SURGEON IDENTIFIED THAT ALTHOUGH THE FEMUR WAS WELL-FIXED, THE FLEXION INSTABILITY REQUIRED REVISION OF THE FEMUR AND TIBIA. THE TIBIAL TRAY WAS LOOSE--INTERFACE UNSPECIFIED. THE PATELLA WAS FOUND TO BE WELL-FIXED, AND WAS RETAINED. FEMUR WAS REPLACED WITH DEPUY ATTUNE REVISION FEMUR SIZE 6, A 30MM SLEEVE, AND 4MM DISTAL AND POSTERIOR AUGMENTS, AND A 14 X 60 FEMORAL STEM. THE TIBIAL TRAY WAS REPLACED WITH AN ATTUNE REVISION TIBIAL TRAY SIZE 6, A 37MM SLEEVE, AND 14 X 60 TIBIAL STEM. THERE WERE NO COMPLICATIONS. DOI: (B)(6) 2015. DOR: (B)(6) 2018. LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 20665303 ↗
• InjuryOct 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENTS RECEIVED FOR DEEP VEIN THROMBOSIS OF LEFT LOWER EXTREMITY. DEVICE AND PROCEDURE(RELATEDNESS). DEVICE RELATED: POSSIBLY. PROCEDURE RELATED: POSSIBLY. DATE OF EVENT: 31 JAN 2019. DATE OF IMPLANT: ON (B)(6) 2018. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: ORAL MEDICATION.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20444678 ↗
• InjuryMay 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DPO_10004_10008 CLINICAL ADVERSE EVENT RECEIVED FOR PAIN IN LEFT KNEE- ASPIRATION. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2013 DATE OF EVENT: (B)(6) 2014 (LEFT KNEE) TREATMENT: MEDICAL INTERVENTION/MODIFICATION.

  Patient problems: Pain

  MAUDE report 19221702 ↗
• InjuryFeb 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE REVISED. THE REASON FOR REVISION WAS INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 18746758 ↗
• InjuryDec 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED LEFT KNEE. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6), 2023. DOR: (B)(6), 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18357946 ↗
• InjuryOct 13, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT INCORRECT FEMUR WAS IMPLANTED. DOI- (B)(6) 2019. DOR- (B)(6) 2022. AFFECTED SIDE- UNKNOWN KNEE.

  Patient problems: Insufficient Information

  MAUDE report 15594906 ↗
• MalfunctionFeb 28, 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

  IT WAS REPORTED THAT THE IMPLANT WAS FOUND TO BE UNSTERILE DUE TO DAMAGE. SURGERY TIME AND PATIENT NOT IMPACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13618650 ↗
• InjurySep 2, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  SURGEON NOTIFIED PRODUCT SPECIALIST, THAT A CASE HE HAD PREVIOUSLY COMPLETED FOR TOTAL KNEE REPLACEMENT, HAD INCORRECT IMPLANT PLACED IN PATIENT. ON REFLECTION, SURGICAL TIMEOUT IN WHICH SURGEON, REPRESENTATIVE, AND NURSING TEAM FAILED TO IDENTIFY THE INCORRECT IMPLANT AT THE TIME. DOI: (B)(6) 2021. DOR: (B)(6) 2021. UNKNOWN SIDE.

  Patient problems: Insufficient Information

  MAUDE report 12413479 ↗
• InjuryAug 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO TIBIA HAD COLLAPSED ON THE LATERAL SIDE AND THE PATIENT ACCORDING TO THE REVISION SURGEON SAID THAT THE PATIENT MUST HAVE FALLEN. SURGEON BELIEVED THE MCL WAS COMPROMISED. SURGEON REMOVED ALL COMPONENTS AND FELT THAT PUTTING A HINGE TKA WAS BEST FOR THE PATIENT MOVING FORWARD. PATIENT HAD A PRIMARY LT TKA DONE (B)(6) 2019, PATIENT THAT TIME HAD "SOFT BONE" ACCORDING TO THE PRIMARY SURGEON. THE SURGEON FELT THAT PUTTING IN A STEM ON TIBIA TRAY WAS BEST FOR PATIENT AND 2 YEARS LATER THE PATIENT NEEDS A REVISION. PATELLA WAS NOT REMOVED. DOI: (B)(6) 2019; DOR: (B)(6) 2021; LEFT KNEE.

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

  MAUDE report 12301401 ↗
• InjuryApr 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. NO SURGICAL DELAY. DOI: (B)(6) 2015, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11614306 ↗
• InjuryFeb 3, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  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 WAS UTILIZED X2. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. REVISION OPERATIVE NOTES (B)(6) 2019 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REVISION DUE TO MECHANICAL LOOSENING. UPON ENTERING THE JOINT, THE FEMORAL COMPONENT WAS NOTED TO BE LOOSE AT THE CEMENT TO IMPLANT INTERFACE. THE FEMORAL, TIBIAL AND INSERT COMPONENTS WERE REVISED WITH COMPETITOR PRODUCT. THE PATELLA WAS LEFT UNREVISED, NO INDICATION OF DEFICIENCY WITH THE PATELLA, INSERT OR TIBIAL BASE. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. DOI: (B)(6) 2017. DOR: (B)(6) 2019. LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 11276878 ↗
• InjuryJan 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ATTUNE KNEE CLAIM RECORD RECEIVED. CLAIM RECORD ALLEGES PAIN, DISCOMFORT, MENTAL SUFFERING AND ASEPTIC LOOSENING OF THE TIBIAL COMPONENT. DEPUY CEMENT WAS USED. DOI: (B)(6) 2018, DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Distress; Fatigue; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 11122900 ↗
• InjuryDec 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIOR TO MANIPULATION OF THE LEFT KNEE ON (B)(6) 2018, THE PATIENT WAS ALSO EXPERIENCING PAIN, SWELLING, STIFFNESS, AND DIFFICULTY WALKING.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Muscular Rigidity; Pain; Swelling/ Edema

  MAUDE report 11038022 ↗
• InjuryOct 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF PRIMARY ATTUNE KNEE CR RP COMPONENTS, WITH PRIMARY CAUSE BEING BEARING SPINOUT. PRIMARY OPERATION WAS ON (B)(6) 2020. PUT IN A 6N LEFT CR FEMUR, SIZE 5 RP BASE PLATE, SIZE 6, 7MM CR RP INSERT AND 32 ANATOMIC PATELLA. PATIENT PRESENTED ON (B)(6) 2020 WITH BEARING SPINOUT, AND HAD A BEARING EXCHANGE TO 10MM INSERT. IT WAS FOUND HERE THAT PCL HAD BEEN RUPTURED POST THE INDEX PROCEDURE. PATIENT WAS PUT INTO A ROM BRACE, BUT DESPITE THAT SUFFERED ANOTHER SPIN OUT WITHIN 2 WEEKS. SO TODAY THEY WERE REVISED WITH REMOVAL OF ALL COMPONENTS, AND REPLACED WITH SZ 4 ATTUNE REVISION RP TIBIA WITH 37 SLEEVE AND 60MM STEM, SIZE 6 REVISION FEMUR WITH POSTERIOR AUGMENTS AND 110 STEM, AND A 6, 16MM REVISION INSERT. IN BALANCING THE KNEE IT WAS APPARENT THAT THE PATIENT'S FLEXION GAP WAS SIGNIFICANTLY LOOSER THAN EXTENSION, SO THE SURGEON SACRIFICED SOME JOINT LINE IN ORDER TO BALANCE EXTENSION TO FLEXION. THE LCL REQUIRED SOME REPAIR, AND THE SURGEON WONDERS WHETHER THIS IS ONE POTENTIAL CAUSE OF SUCH SIGNIFICANT INSTABILITY. DOI: (B)(6) 2020, DOR: (B)(6) 2020 (INSERT EXCHANGE), DOR: (B)(6) 2020 (TOTAL REVISION), LEFT KNEE.

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

  MAUDE report 10719439 ↗
• InjurySep 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATE: MEDICAL RECORDS RECEIVED ON AD 21 AUG 2020 WERE REVIEWED ON AD 01 SEP 2020 BY A CLINICIAN TO IDENTIFY PATIENT HARMS/PRODUCT ISSUES. PATIENT RECEIVED A LEFT PRIMARY ATTUNE TO TREAT PREMATURE OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT RECEIVED A LEFT KNEE REVISION TO TREAT PAIN AND INSTABILITY SECONDARY TO LOOSENING OF THE TIBIAL TRAY. UPON ENTERING THE JOINT, THE SURGEON IDENTIFIED AND EXCISED SYNOVITIS AND SWELLING. THE TIBIAL TRAY WAS LOOSENED AND DEBONDED AT THE CEMENT TO IMPLANT INTERFACE AND REMOVED. THE FEMORAL COMPONENT WAS WELL-FIXED BUT REVISED. THE SURGEON NOTES THERE WAS AORI TYPE 2A BONE LOSS OF THE FEMUR AND TIBIA REQUIRING RECONSTRUCTION. THE PATELLA WAS WELL-FIXED AND RETAINED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE EXPLANTED TIBIAL INSERT. THE PATIENT WAS REVISED WITH A COMPETITOR CONSTRUCT UTILIZING COMPETITOR CEMENT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2015. DOR: (B)(6) 202. LEFT KNEE.

  Patient problems: Edema; Injury; No Code Available; Pain

  MAUDE report 10535749 ↗
• InjuryJan 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN, DISCOMFORT AND LOOSENING OF THE TIBIAL COMPONENT AT BONE TO CEMENT AND CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. DOI: 2-3 YEARS AGO; DOR: (B)(6) 2019 LEFT KNEE.

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

  MAUDE report 9571748 ↗
• InjuryNov 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED AD 17 JUNE 2019. THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO PAIN, INSTABILITY, ADHESIONS, AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE PRE- AND -POST-OPERATIVE DIAGNOSIS ALSO INDICATED FEMORAL COMPONENT LOOSENING, HOWEVER, THERE IS NO MENTION OF FEMORAL COMPONENT LOOSENING WITHIN THE OPERATIVE NOTE. THE FEMORAL COMPONENT WAS REMOVED USING AN OSTEOTOME AND SAW. THE PATELLA COMPONENT WAS NOT REVISED. COMPETITOR CEMENT WAS USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2017. DOR: (B)(6) 2018; LEFT KNEE.

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

  MAUDE report 9278548 ↗
• InjuryAug 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION TKR; DR (B)(6) HOSPITAL (B)(6) 2019; PATIENT UNDERWENT PRIMARY TKR APPROXIMATELY 3 YEARS AGO (DATE, SURGEON AND HOSPITAL UNKNOWN AT PRESENT ( MATER BRISBANE); REASON FOR REVISION: PAIN AND LIMITED RANGE OF MOTION. THE PATIENT HAS REPORTED THAT POST OPERATIVELY THE KNEE DID NOT DO WELL AND HAD A LIMITED RANGE OF MOTION. THE KNEE WAS MANIPULATED ON MORE THAN ONE OCCASION (SURGEON AND DATES UNKNOWN), PATIENT HAS PRESENTED TO DR WITH A PAINFUL AND UNCOMFORTABLE KNEE, WITH A LIMITED RANGE OF MOTION (+- 50 TO 70 DEGREES). A DECISION WAS MADE TO REVISE THE KNEE (B)(6) 2019. ON OPENING THE KNEE THE COMPONENTS APPEARED TO BE WELL FIXED. THE UN-RESURFACED PATELLA HAS SOME UNUSUAL WEAR PATTERNS. THE COMPONENTS WERE REMOVED AND REVISED WITH AN ATTUNE RP REVISION. THE PATELLA WAS RESURFACED.

  Patient problems: Discomfort; Loss of Range of Motion; No Code Available; Pain; Scar Tissue

  MAUDE report 8945723 ↗
• InjuryAug 12, 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, INSTABILITY, SCARRING, AND ARTHROFIBROSIS. THE SURGEON NOTED THE PRE-AND-POST-OPERATIVE DIAGNOSIS OF ASEPTIC LOOSENING OF LEFT TOTAL KNEE. HOWEVER, THERE WAS NO INDICATION OF LOOSENING WITHIN THE REVISION OPERATIVE NOTE. DEPUY CEMENT WAS USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2016. DOR: (B)(6) 2017, LEFT KNEE.

  Patient problems: Fibrosis; No Code Available; Pain; Scarring

  MAUDE report 8885135 ↗