ATTUNE 1504-40-105Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10603295042181), received between Jul 19, 2018 and Mar 17, 2026 — classified as 44 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (4 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Apr 16, 2018Class IITerminated

   There may be burrs on the extraction hole threads.

   Z-1703-2018 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO FRACTURE ABOVE THE REVISION COMPONENTS. AFFECTED SIDE-LEFT KNEE,

  Patient problems: Limb Fracture

  MAUDE report 24618494 ↗
• MalfunctionJan 2, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT FEMORAL IMPLANT WAS OPENED AND THE HOLES FOR THE AUGMENTS WERE FILLED IN WITH A PLASTIC PLUG. AFFECTED SIDE: LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23943014 ↗
• InjuryDec 23, 2025Loss of or Failure to Bond; No Apparent Adverse Event; Loss of or Failure to Bond; No Apparent Adverse Event

  SUBJECT ID: (B)(6) STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR TIBIAL AND FEMORAL COMPONENT LOOSENING ON INDEX KNEE DEVICE AND PROCEDURE (RELATEDNESS) DEVICE RELATED: POSSIBLY PROCEDURE RELATED: DEFINITELY. DATE OF EVENT: UN JAN 2025 DATE OF IMPLANT: (B)(6) 2020 DATE OF REVISION: NO INFORMATION PROVIDED DEVICE LOCATION: LEFT. TREATMENT/IMPACT: OTHER: TRUE. IF OTHER ¿ SPECIFY: PLANNED TO HAVE REVISION SURGERY IN (B)(6) OF 2026.

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

  MAUDE report 23880545 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A REVISION KNEE IN 2023; THERE WAS A PROXIMAL STRUT ALLOGRAFT PUT ON AT SOME POINT AFTER THE REVISION. THE PATIENT HAD PROXIMAL FEMUR PAIN, THE BONE SCAN SHOWED LOOSENING. A REVISION WAS PLANNED. KNOCKED THE SIZE 5 FEMUR OFF, THERE WAS NO LOOSENING OF OUR FEMORAL SLEEVES OR TIBIAL IMPLANTS. THE ALLOGRAFT WAS LOOSE, AND CABLES WERE LOOSE. THE SURGEON DECIDED TO RETRO FIT A NEW CRS REVISION SIZE 5 LEFT FEMORAL COMPONENT BACK INTO THE WELL INGROWN SLEEVE. DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 23880102 ↗
• InjuryNov 14, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  ADDITIONAL INFORMATION RECEIVED: TREATMENT/IMPACT: DIAGNOSTIC INTERVENTION: NO => YES.

  Patient problems: Pain

  MAUDE report 23553892 ↗
• InjuryAug 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED TO A CEMENT SPACER DUE TO INFECTION - ALL REVISION COMPONENTS WERE REMOVED AND CEMENT SPACER PLACED WHILE PATIENT WAS ON ANTIBIOTICS IN THE HOPES SHE WOULD CLEAR THE INFECTION. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22828093 ↗
• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF THE FEMORAL KNEE FOR STIFFNESS. COMPONENTS WERE NOT LOOSE OR DAMAGED. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 22384927 ↗
• InjuryMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST OPERATIVE X-RAYS SHOWED A FEMUR FRACTURE. SURGEON DECIDED TO REMOVE IMPLANTS AND REDUCE FRACTURE/REPOSITION KNEE REVISION. NO COMPLAINTS ABOUT INSTRUMENTATION OR IMPLANTS AND THERE WAS NO DELAY TO SURGERY TIME. THE FEMORAL BONE FRACTURED, THE IMPLANT WAS INTACT. DOI: (B)(6) 2025, DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Limb Fracture

  MAUDE report 22034447 ↗
• InjuryMay 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH REDNESS AND A WARM KNEE 3 WEEKS FROM REVISION OF THE LEFT TOTAL KNEE. SURGEON PERFORMS A THOROUGH I&D WITH INSERT EXCHANGE AND PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS WITH NO DELAY NOR PATIENT HARM. DURING DEBRIDEMENT, SURGEON NOTICES WHAT APPEARS TO BE A CRACK IN THE ANTERIOR FEMUR AND CHOSES TO PLACE A CABLE IN THIS AREA. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Erythema; Limb Fracture

  MAUDE report 21994478 ↗
• InjuryMar 26, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT FEMUR WAS LOOSE; SURGEON REVISED FEMUR AND POLY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 21700591 ↗
• InjuryJan 22, 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 PAIN. NO SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 21208468 ↗
• InjuryJan 14, 2025Adverse 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 INTRA-OP FEMUR FRACTURE. RELATED TO DEVICE: POSSIBLY. RELATED TO PROCEDURE: DEFINITELY. DATE OF EVENT: (B)(6) 2024. DATE OF IMPLANT: (B)(6) 2024. DATE OF REVISION: NO REVISION. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: FIXATION DURING SURGERY.

  Patient problems: Limb Fracture

  MAUDE report 21147925 ↗
• InjuryJan 13, 2025Adverse 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 FEMUR FRACTURE INTRA-OP IS THIS EVENT RELATED TO THE STUDY DEVICE? POSSIBLY. IS THIS EVENT RELATED TO THE STUDY PROCEDURE? DEFINITELY. DATE OF EVENT: (B)(6) 2024. DATE OF IMPLANT: (B)(6) 2024. DATE OF REVISION: NO REVISION. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: OPEN REDUCTION INTERNAL FIXATION: YES. DEPUY SYNTHES PRODUCTS USED: PRODUCT DETAILS: COMPONENT TYPE: FEMORAL COMPONENT. CATALOG NUMBER: 150440105. LOT NUMBER ID: M73T63. UDI: (B)(4). COMPONENT TYPE: TIBIAL BASE COMPONENT: CATALOG NUMBER: 150660005. LOT NUMBER ID: 4558418. UDI: (B)(4). COMPONENT TYPE: TIBIAL STEM. CATALOG NUMBER: 151214030. LOT NUMBER ID: D23123395. UDI: (B)(4). COMPONENT TYPE: TIBIAL INSERT COMPONENT. CATALOG NUMBER: 151710506. LOT NUMBER ID: 4306682. UDI: (B)(4). COMPONENT TYPE: PATELLA. CATALOG NUMBER: 151820035. LOT NUMBER ID: 4311257. UDI: (B)(4). COMPONENT TYPE: CEMENT. CATALOG NUMBER: 66044274. LOT NUMBER ID: Y123. UDI: (B)(4).

  Patient problems: Limb Fracture

  MAUDE report 21136704 ↗
• InjuryOct 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). STUDY NO: DSJ_2016_02. CLINICAL ADVERSE EVENTS RECEIVED FOR INSTABILITY. DATE OF EVENT: 24 OCT 2019. DATE OF IMPLANT: (B)(6) 2019. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: HOSPITALIZATION AND CLOSED REDUCTION/MANIPULATION.

  Patient problems: Joint Laxity

  MAUDE report 20534128 ↗
• InjuryJul 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVENT DATE: BLANK ALERT DATE: 28-JUN-2019 COUNTRY OF EVENT: OUS PROCEDURE: TYPE OF REVISION - OPERATIVE DETAILS PART 1: FULL PROCEDURE: KNEE REVISION USING ATTUNE - OPERATIVE DETAILS PART 2: PS RP OPERATIVE SIDE: LEFT DATE OF SURGERY: (B)(6) 2019 EVENT DESCRIPTION (DIAGNOSIS): OPERATIVE WOUND DEHISCED CENTRAL 8CMS: FURTHER REVISION SURGERY REQUIRED. UPDATED EVENT DESCRIPTION: CLINICAL ADVERSE EVENT RECEIVED FOR OPERATIVE WOUND DEHISCED CENTRAL 8CMS: WOUND DEHISCENCE REQUIRING DAIR. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2019 DATE OF EVENT: 26 JUN 2019 (LEFT KNEE) TREATMENT: IRRIGATION & DEBRIDEMENT.

  Patient problems: Wound Dehiscence

  MAUDE report 19645902 ↗
• MalfunctionFeb 16, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT FEMUR DID NOT SEAT OR FIT LIKE TRIAL FEMURS HAD AND PATIENT EXPERIENCED LARGE VARIANCE ON MEDIAL SIDE THAT WAS NOT PRESENT IN ANY OF THE PREP OR TRIALING PHASES. DOE: (B)(6) 2024 AFFECTED SIDE: LEFT KNEE.

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

  MAUDE report 18720939 ↗
• InjuryFeb 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A. WAS THERE A SURGERY DELAY? IF YES, WHAT WAS THE DURATION OF THE DELAY? NO.

  Patient problems: Unspecified Infection

  MAUDE report 18697422 ↗
• InjuryDec 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR MEDIAL CONDYLE FRACTURE OF FEMUR. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(3) 2023. DATE OF EVENT: (B)(3) 2023. (LEFT KNEE). TREATMENT: OPEN REDUCTION INTERNAL FIXATION.

  Patient problems: Limb Fracture

  MAUDE report 18291150 ↗
• InjuryJun 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RIGHT TKA WAS INFECTED. ATTUNE REVISION FOR REVISION OF UNI CONDYLAR, REMOVED = SPACER , IMPLANTATS SONICATION . DOI: (B)(6) 2022. DOE: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17181613 ↗
• InjuryMar 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT, MALE, OPERATED ON THE LEFT SIDE FOR A KNEE REVISION, FOR A POSTOPERATIVE INFECTION.(SAPHEPIDERMIDIS). DATE OF THE FIRST INTERVENTION THE (B)(6) 2023. DATE OF REVISION (B)(6) 2023. THE REMOVED IMPLANTS WERE DISCARDED.

  Patient problems: Unspecified Infection

  MAUDE report 16655285 ↗
• InjuryAug 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT HE NEED TO SPEAK TO SOMEONE WITH THE DEPUY DIVISION. HE HAS A FEW QUESTIONS IF THERE IS A RECALL WITH THE PRODUCT. HE HAD SOME PROBLEMS WITH THE PRODUCT THAT WAS ON HIS LEFT LEG AND IT WAS SUPPOSED TO LAST 10-15 YEARS BUT IT ONLY LASTED FOR 2 YEARS(SCN). DOI: UNKNOWN. DOR: UNKNOWN. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Discomfort; Pain

  MAUDE report 15266088 ↗
• InjuryAug 2, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2020, THE PATIENT HAD A LEFT TOTAL KNEE REPLACEMENT REVISION TO ADDRESS FAILED LEFT TOTAL KNEE ARTHROPLASTY. THE INDICATIONS FOR SURGERY INCLUDED PAIN AND DYSFUCTION. MEDICAL RECORDS FROM (B)(6) 2020, NOTE THE PATIENT HAS A HISTORY OF PAIN FOLLOWING INJURY. RADIOGRAPHS WERE REPORTED TO SHOW SUBCUTANEOUS EMPHYSEMA. DURING THE PROCEDURE THE SURGEON OBSERVED THAT THE FEMORAL COMPONENT WAS NOTED TO BE GROSSLY LOOSE, NO INTERFACE PROVIDED. THE TIBIAL COMPONENT WAS NOTED TO BE WELL FIXED AND WAS RETAINED. DEPUY COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE. DOI: (B)(6) 2018. DOR: (B)(6) 2020. LEFT KNEE.

  Patient problems: Pain

  MAUDE report 15145698 ↗
• InjuryJun 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2020. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 14714378 ↗
• InjuryMay 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PREVIOUS ATTUNE REVISION PERFORMED ON (B)(6) 2022 AT (B)(6). HAS PRESENTED AS INFECTED, WAS TRANSFERRED TO (B)(6) WITH SOME ASSOCIATED SKIN COMPROMISE, WILL NEED PLASTIC SURGERY POTENTIALLY IF FREE FLAP OF SKIN REQUIRED, THIS IS THE REASON FOR TRANSFER TO (B)(6). PROCEDURE TODAY WAS A WASH OUT AND DEBRIDEMENT WITH EXCHANGE OF POLYETHYLENE INSERT. DOI: (B)(6) 2022; DOR: (B)(6) 2022 UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14470458 ↗
• InjuryMar 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POLY CHANGE FROM REVISION KNEE 3 YEARS AGO. NO ISSUE WITH POLY, LIMITED FLEXSION ~85°. PRESENT IN BOTH KNEES (ONE DPS / ONE EXATECH). DOI: (B)(6) 2019.

  Patient problems: Inflammation; Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 13900352 ↗