ATTUNE 1504-10-124Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10603295041696), received between Jun 1, 2018 and Mar 6, 2025 — classified as 40 injuries, 1 malfunction.

The most frequently reported specific device problem is “Malposition of Device” (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 41 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH A MANIPULATION UNDER ANESTHESIA OF THE LEFT TOTAL KNEE ARTHROPLASTY, AS WELL AS AN INTRA-ARTICULAR STEROID INJECTION OF THE LEFT KNEE, ADDRESSING KNEE STIFFNESS. THERE WERE NO COMPLICATIONS. AFFECTED KNEE: LEFT.

  Patient problems: Muscular Rigidity

  MAUDE report 21535503 ↗
• InjuryAug 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT COULD NOT GET FULL EXTENSION. KNEE FELT TOO TIGHT. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Joint Laxity; Muscular Rigidity

  MAUDE report 19992127 ↗
• InjuryJan 29, 2024Migration; Migration

  PATIENT WAS BEING REVISED DUE TO PAIN AND STIFFNESS IN THE LEFT KNEE. IT WAS DETERMINED THE IMPLANTS WERE PUT IN SLIGHT VALGUS ALIGNMENT AND THE FEMORAL COMPONENT HAD AN AREA OF LOOSENING. BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER UNKNOWN. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- UNKNOWN. DOR- (B)(6) 2024. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 18596756 ↗
• InjuryOct 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO A DISTAL FEMUR FRACTURE. THERE WAS LOOSENING REPORTED AT THE FEMUR ON BONE TO CEMENT INTERFACE. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE : LEFT KNEE.

  Patient problems: Limb Fracture

  MAUDE report 17930162 ↗
• InjurySep 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD RESECTION FOR STAPH EPI INFECTION. DOI: (B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17804560 ↗
• InjuryJul 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ATTUNE LITIGATION RECORD RECEIVED. LITIGATION RECORD ALLEGES DEFECTIVE DEPUY ATTUNE KNEE SYSTEM, DEFECTIVE SMARTSET HV BONE CEMENT 40G, PAIN, SWELLING, JOINT STIFFNESS, NICKEL ALLERGY, SUFFERING, IMPAIRMENT, DISFIGUREMENT, PECUNIARY LOSS, ECONOMIC DAMAGES AND LOOSENING OF THE TIBIAL COMPONENT AT AN UNKNOWN INTERFACE AND ASEPTIC LOOSENING. DEPUY CEMENT WERE USED. DOI: (B)(6) 2015. DOR: (B)(6) 2016. LEFT KNEE.

  Patient problems: Adhesion(s); Deformity/ Disfigurement; Hypersensitivity/Allergic reaction; Muscular Rigidity; Pain; Swelling/ Edema

  MAUDE report 17393450 ↗
• InjuryOct 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RETURNED TO SURGERY FOR CONTINUES KNEE INSTABILITY. HER ATTUNE KNEE WAS REMOVED AND AN ATTUNE REVISION WAS PLACED. NO LOOSENING, BREAKAGE OR DELAYS. DOI: (B)(6) 2017. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15679749 ↗
• InjuryAug 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS (B)(4) IS RELATED TO (B)(4) WHICH REPORTS THAT FREQUENT DISLOCATIONS OCCURRED AFTER THE MANUAL REDUCTION. THIS PC REPORTS THAT THE POSTERIOR DISLOCATION OCCURRED DUE TO FALL. IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE TOTAL KNEE ARTHROPLASTY WITH THE ATTUNE FOR THE OSTEOARTHRITIS OF THE KNEE JOINT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE PATIENT FELL, AND POSTERIOR DISLOCATION OCCURRED IN (B)(6) 2022. THE SURGEON PERFORMED MANUAL REDUCTION AND USED A BRACE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Fall

  MAUDE report 15224251 ↗
• InjuryAug 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS (B)(4) IS RELATED TO (B)(4) WHICH REPORTS THAT THE POSTERIOR DISLOCATION OCCURRED DUE TO FALL. THIS PC REPORTS THAT FREQUENT DISLOCATIONS OCCURRED AFTER THE MANUAL REDUCTION. IT WAS REPORTED THAT ON UNKNOWN DATE IN (B)(6) 2022, THE PATIENT UNDERWENT MANUAL REDUCTION DUE TO POSTERIOR DISLOCATION CAUSED BY A FALL. HOWEVER, FREQUENT DISLOCATION OCCURRED. ON (B)(6) 2022, THE SURGEON REMOVED ALL THE IMPLANTS AND INSERTED THE ATTUNE CRS, THE ATTUNE FB. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2021. DOR: (B)(6) 2022. UNKNOWN SIDE.

  Patient problems: Fall; Insufficient Information; Joint Laxity

  MAUDE report 15190923 ↗
• InjuryJun 24, 2022Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT THE TOTAL KNEE ARTHROPLASTY WITH THE ATTUNE FOR THE OSTEOARTHRITIS OF THE LEFT HIP JOINT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE TOTAL KNEE ARTHROPLASTY FOR THE RIGHT HIP JOINT WAS TO BE PERFORMED. THE PATIENT COMPLAINED THAT SHE DID NOT FEEL PAIN; HOWEVER, THERE WAS DISCOMFORT AND UNUSUAL NOISE WHEN STANDING UP FROM A SITTING POSITION. IN ADDITION, PATELLAR CREPITUS IS SUSPECTED. ON (B)(6) 2020, THE PATIENT UNDERWENT THE ENDOSCOPIC SURGERY BEFORE THE TOTAL KNEE ARTHROPLASTY FOR THE RIGHT HIP JOINT. IN THE ENDOSCOPIC SURGERY, SYNOVIAL MEMBRANE BEHIND THE QUADRICEPS MUSCLE WAS RESECTED AND HEMOSTATIC USING A SHAVER AND A VULCAN. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ACCORDING TO THE SURGEON, THIS WAS THE FIRST TIME HE HAD SEEN PATELLAR CREPITUS, EVEN THOUGH HE HAS BEEN USING THE ATTUNE FOR MANY YEARS. THE SURGEON UNDERSTANDS THAT THE ATTUNE IS LESS LIKELY TO OCCUR PATELLAR CREPITUS WITH THIS DESIGN THAN WITH PREVIOUS PFCS MODELS. THE PATELLA HAS BEEN REPLACED WITH AN APPROPRIATELY SIZED IMPLANTS AND THE PATELLAR OSTEOPHYTES HAVE BEEN CUT WITH A B

  Patient problems: Discomfort; Synovitis; Unspecified Musculoskeletal problem; Unspecified Tissue Injury

  MAUDE report 14800467 ↗
• InjuryApr 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT FELL AND SUFFERED A DISTAL FEMORAL FRACTURE OF HER TOTAL KNEE. SHE WAS REVISED WITH A STEM AND SLEEVE. ORIGINAL SURGERY WAS WITHIN A COUPLE WEEKS OF HER PRIMARY TOTAL KNEE BY SURGEON.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 14203753 ↗
• InjuryDec 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO RUPTURED PATELLA TENDON. DURING REPAIR OF TENDON THE SURGEON SWAPPED THE POLY INSERT. DOI: (B)(6) 2021, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Unspecified Musculoskeletal problem

  MAUDE report 12925824 ↗
• InjuryAug 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT UNDERWENT A SECOND LEFT KNEE REVISION TO ADDRESS PAIN. THE SURGEON NOTED THE REMOVAL OF SCAR TISSUE. THE TIBIAL INSERT, TIBIAL TRAY, AND FEMORAL COMPONENT WERE REVISED. THE PATELLAR COMPONENT WAS RETAINED. THE SURGEON NOTED MINIMAL BONE LOSS WITH REMOVAL OF THE FEMORAL COMPONENT. THE PATIENT WAS REVISED WITH DEPUY PRODUCTS. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2018 INSERT; DOI: (B)(6) 2017 FEMORAL, TIBIAL TRAY; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 12290234 ↗
• InjuryJun 29, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  ON(B)(6) 08 DEC 2020, THE PATIENT HAD A LEFT TOTAL KNEE REPLACEMENT REVISION TO ADDRESS FAILED LEFT TOTAL KNEE. THE PATELLA WAS IN GOOD POSITION AND WELL-SIZED AND WAS NOT REVISED. THE FEMORAL COMPONENT APPEARED TO BE LOOSE AT THE IMPLANT/CEMENT INTERFACE. THE TIBIAL TRAY WAS LOOSE AT THE IMPLANT/CEMENT INTERFACE. THE INSERT WAS REVISED WITHOUT ALLEGATION OF DEFICIENCY. COMPETITOR COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE. DOI:(B)(6). 2017 DOR: (B)(6). 2020 (LEFT KNEE).

  Patient problems: Insufficient Information

  MAUDE report 12088155 ↗
• InjuryMar 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO UNSTABLE KNEE. DOI: UNKNOWN DOR: (B)(6) 2021 LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11567966 ↗
• InjuryFeb 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A SYSTEMIC INFECTION WHICH SETTLED IN HER KNEE AND SHOULDER. FRANK PUS WAS ENCOUNTERED. THE KNEE WAS WASHED OUT AND A NEW INSERT WAS PLACED ON (B)(6) 2020. SHE RETURNED TO THE OR TODAY AND ALL THE IMPLANTS WERE REMOVED. A TC3 FEMUR AND A TC3 RP INSERT WERE PLACED AS SPACERS. NO SURGICAL DELAY. DOI: (B)(6) 2020 (TRAY, FEMORAL, INSERT, PATELLA), DOR: (B)(6) 2020 (INSERT), DOR: (B)(6) 2021 (ALL IMPLANT), LEFT KNEE.

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

  MAUDE report 11292688 ↗
• InjuryJan 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY OPERATIVE NOTES (B)(6) 2016 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REPLACEMENT DUE TO END STAGE OSTEOARTHRITIS. THE PATELLA WAS RESURFACED, AND COMPETITOR CEMENT 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 PAIN AND LOOSENING OF THE TIBIAL COMPONENT. UPON ENTERING THE JOINT, PROFOUND STIFFNESS AND SIGNIFICANT ADHESIONS WERE ENCOUNTERED AND REMOVED. THE TIBIAL COMPONENT WAS NOTED TO BE LOOSE AT THE CEMENT TO IMPLANT INTERFACE. FEMUR, INSERT AND TIBIAL COMPONENT WERE REVISED. DEPUY PRODUCTS WERE IMPLANTED ALONG WITH COMPETITOR CEMENT. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. DOI: (B)(6) 2016. DOR: (B)(6) 2018. LEFT KNEE.

  Patient problems: Adhesion(s); Muscular Rigidity; Pain

  MAUDE report 11155080 ↗
• InjuryJan 12, 2021Adverse 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 NOT RESURFACED, AND COMPETITOR CEMENT WAS UTILIZED. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. REVISION OPERATIVE NOTES (B)(6) 2020 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REVISION DUE TO ASEPTIC LOOSENING. UPON ENTERING THE JOINT, IT IS INDICATED THAT SCARRING WAS REMOVED. THE TIBIAL COMPONENT WAS LOOSE, INTERFACE NOT PROVIDED. THE FEMORAL AND INSERT COMPONENTS WERE ALSO REVISED WITHOUT INDICATION OF PRODUCT DEFICIENCY. DEPUY PRODUCTS WERE IMPLANTED, THE PATELLA WAS RESURFACED AND COMPETITOR CEMENT WAS UTILIZED. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. DOI: (B)(6) 2017, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: Adhesion(s)

  MAUDE report 11154963 ↗
• InjuryNov 16, 2020Difficult to Insert; Difficult to Advance; Difficult to Insert; Difficult to Advance

  FEMORAL IMPLANT DID NOT SEAT WHILE CEMENTING AND HUNG UP MEDIALLY. A LATERAL CONDYLE FRACTURE OCCURRED WHILE IMPACTING. THE ORIGINAL IMPLANT WAS REMOVED. THE FRACTURE WAS ADDRESSED WITH LAG SCREWS. A NEW FEMORAL COMPONENT WAS IMPLANTED WITHOUT ISSUE.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 10843010 ↗
• InjuryMay 7, 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, STIFFNESS, POSSIBLE ALLERGIC REACTION TO NICKEL, AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE FEMORAL COMPONENT WAS WELL-FIXED BUT REVISED. THE PATELLAR COMPONENT WAS RETAINED. UNKNOWN CEMENT WAS USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2017. DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: Hypersensitivity/Allergic reaction; Muscular Rigidity; No Code Available; Pain

  MAUDE report 10033489 ↗
• InjuryMar 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO CONSISTENT PAIN AND SWELLING. REVISION CONSISTED OF A SYNOVECTOMY, A POLY SWAP AND A CONVERSION OF AN ANATOMIC PATELLA TO A DOME PATELLA. THE QUAD TENDON HAS SLIGHTLY PULLED AWAY FROM THE ATTACHMENT TO THE NATIVE PATELLA. DOI: (B)(6) 2016, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: Edema; No Code Available; Pain

  MAUDE report 9819570 ↗
• InjuryFeb 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT STARTED COMPLAINING OF FEMORAL PAIN APPROX. SIX MONTHS POSTOP. PAIN LEVELS INTENSIFIED AND WAS ISOLATED TO THE DISTAL FEMUR. BONE SCAN OF BOTH THE FEMUR AND TIBIA HIGHLIGHTED "HEAT" SPOTS AT BOTH LUG POINTS ON THE FEMORAL CONDYLES. THE SURGEON CARRIED OUT REVISION SURGERY ON THE (B)(6) 2020 REMOVING THE FEMORAL COMPONENT AND TIBIAL INSERT REPLACING THE FEMORAL COMPONENT WITH A STEM AND SLEEVE AND THE INSERT WAS UPSIZED. FEMALE PATIENT INITIALS: (B)(6).

  Patient problems: No Code Available; Pain

  MAUDE report 9714308 ↗
• InjuryJan 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2015 SECONDARY TO PAIN. ATTUNE IMPLANTS WERE USED. DEPUY CEMENT X1 WAS USED. THE PATELLA WAS RESURFACED. NO INTRAOPERATIVE COMPLICATIONS NOTED. THE PATIENT UNDERWENT A REVISION ON THE LEFT KNEE ON (B)(6) 2017 SECONDARY TO PAIN, STIFFNESS AND SUSPECTED LOOSENING. INTRAOPERATIVELY, THE SURGEON DISCOVERED EVIDENCE OF KELOID FROM PREVIOUS SURGERY; AND NOTED EXCESS SCAR TISSUE. THE PREOPERATIVE DIAGNOSIS STATES POSSIBLE LOOSENING, HOWEVER, INTRAOPERATIVELY, THE SURGEON STATED THAT HE REMOVED THE TIBIAL COMPONENT WHICH HAD A GREAT DEAL OF CEMENT POSTERIORLY WHICH ALSO WAS REMOVED; SURGICAL NOTES ARE UNCLEAR AS TO WHETHER LOOSENING WAS CONFIRMED AT THIS TIME. THERE WAS EVIDENCE OF A BLEED FROM THE POSTERIOR ASPECT OF THE FEMUR WHICH REQUIRED CONSULT WITH A VASCULAR SURGEON AND REPAIR. PMH: OSTEOARTHROPATHY, LEFT KNEE; TRICOMPARTMENTAL ARTHRITIS, LEFT KNEE. DOI: (B)(6) 2015. DOR: (B)(6) 2017.

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

  MAUDE report 9558257 ↗
• InjuryJan 3, 2020Malposition of Device; Malposition of Device

  REVISION OF THE LEFT KNEE SECONDARY TO PAIN, SWELLING, STIFFNESS AND SUSPECTED MALROTATION. INTRAOPERATIVELY, THE SURGEON DISCOVERED TIBIAL LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. DUE TO THE MALROTATION, A COMPLETED REVISION OF THE TIBIAL AND FEMORAL COMPONENTS TO A ROTATION PLATFORM DESIGN. DOI: (B)(6) 2013; DOR: (B)(6) 2016; (LEFT KNEE).

  Patient problems: Edema; Pain

  MAUDE report 9547500 ↗
• InjuryDec 2, 2019Malposition of Device; Appropriate Device Problem Term/Code Not Available; Noise, Audible; Malposition of Device; Appropriate Device Problem Term/Code Not Available; Noise, Audible

  THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO PAIN, PATELLA MALTRACKING, CREPITUS, AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE PATELLA WAS NOTED TO TRACK WITH SIGNIFICANT LATERAL TILT AND THERE WAS CONTACT OF THE LATERAL PATELLA BONE WITH THE FEMORAL COMPONENT. DOI: (B)(6) 2017; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9396006 ↗