ATTUNE 1504-40-107Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10603295042204), received between Oct 5, 2018 and Jul 27, 2026 — classified as 33 injuries.

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

• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient contracted MRSA, all implants removed and replaced with antibiotic spacer.DOI: Unknown.DOR: Unknown.Affected Side: Left Knee.

  Patient problems: Unspecified Infection

  MAUDE report 50039202 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ALL COMPONENTS WERE REMOVED DUE TO INFECTION AND WASH OUT. THERE WAS NO HARM DONE TO THE PT. NOR DELAY TO THE CASE. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25042466 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24871063 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR ARTERITIS STADE 4 + INFECTION OF LEFT TKA, DEVICE AND PROCEDURE (RELATEDNESS), DEVICE RELATED: POSSIBLY, PROCEDURE RELATED: POSSIBLY, DATE OF EVENT: 16 JUL 2025, DATE OF IMPLANT: ON (B)(6) 2022, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: LEFT. TREATMENT/IMPACT: HOSPITALIZATION (INITIAL OR PROLONGED): YES; WAS THE SUBJECT READMITTED TO HOSPITAL: YES (READMISSION ON (B)(6) 2025); INJECTED MEDICATION: YES; ORAL MEDICATION: YES; COMPONENTS REMOVED (FEMORAL COMPONENT, FEMORAL STEM, TIBIAL INSERT, TIBIAL BASE). DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 150440107, LOT NUMBER: JG6793, COMPONENT TYPE: FEMORAL COMPONENT, DESCRIPTION: ATTUNE KNEE SYSTEM REVISION CRS FEMORAL CEMENTED LEFT SIZE 7, CATALOG NUMBER: 150660005, LOT NUMBER: 3733875, COMPONENT TYPE: TIBIAL BASE COMPONENT, DESCRIPTION: ATTUNE KNEE SYSTEM REVISION ROTATING PLATFORM TIBIAL BASE CEMENTED SIZE 5, CATALOG NUMBER: 151710706, LOT NUMBER: 9898466, COMPONENT TYPE: TIBIAL INSERT COMPONENT, DESCRIPTION: ATTUNE KNEE SYSTEM REVISION CRS ROTATING PLATFORM INSERT AOX SIZE 7 6MM, CONCOMITANT PRODUCTS: CATALOG NUMBER: 66017750, LOT NUMBER: 61

  Patient problems: Arthritis; Unspecified Infection

  MAUDE report 24052149 ↗
• InjuryDec 29, 2025Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO FEMORAL COMPONENT LOOSENED AND WAS CAUSING PAIN AND DISCOMFORT IN PATIENTS LEFT KNEE. EVALUATION AND XRAY CONFIRMED DIAGNOSIS. FEMORAL COMPONENT WAS REVISED TO CORRECT PATIENT ISSUE. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Discomfort; Inadequate Osseointegration; Pain

  MAUDE report 23908373 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS REMOVAL TOTAL KNEE DUE TO INFECTION STAGE 1. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23467007 ↗
• InjuryOct 23, 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 POST-OPERATIVE ANEMIA. DEVICE RELATED: DEFINITELY NOT. PROCEDURE RELATED: DEFINITELY. DATE OF EVENT: 15 FEB 2020. DATE OF IMPLANT: (B)(6) 2020. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: 2 X ERYTHROCYTE CONCENTRATE.

  Patient problems: Anemia

  MAUDE report 23368130 ↗
• InjuryOct 22, 2025Adverse 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 INFECTION OF LEFT TKA DEVICE RELATED: DEFINITELY PROCEDURE RELATED: POSSIBLY DATE OF EVENT: 13 MAY 2025 DATE OF IMPLANT: (B)(6) 2022 DATE OF REVISION: NO INFORMATION PROVIDED DEVICE LOCATION: LEFT. TREATMENT/IMPACT: HOSPITALIZATION, REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OR DAMAGE, READMITTED TO HOSPITAL (B)(6) 2025), DIAGNOSTIC INTERVENTION. TREATMENT/IMPACT: STOPPING ANTIBIOTICS AND DECISION TO FOLLOW UP WITH A FISTULISATION.

  Patient problems: Unspecified Infection

  MAUDE report 23357306 ↗
• InjuryOct 15, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO FEMORAL COMPONENTS WERE REMOVED DUE TO ASEPTIC LOOSENING. IT WAS STATED THAT THE FEMUR & SLEEVE WERE LOOSE. LOOSENING INTERFACE WAS MARKED AS NON-CEMENTED. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23302878 ↗
• InjuryJul 25, 2025Adverse 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) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 22612876 ↗
• InjuryJul 2, 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. DOI: (B)(6) 2021. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 22387115 ↗
• InjuryMay 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6), STUDY NO: (B)(6). EVENT DETAILS. CLINICAL ADVERSE EVENT RECEIVED FOR RELAPSE OR NEW INFECTION OF LEFT TKP. DEVICE AND PROCEDURE (RELATEDNESS), DEVICE: DEFINITELY, PROCEDURE: POSSIBLY, DATE OF EVENT: 17 APR 2025, DATE OF IMPLANT: (B)(6) 2022, DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: HOSPITALIZATION (INITIAL OR PROLONGED), INJECTED MEDICATION AND DIAGNOSTIC INTERVENTION DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 150440107, LOT NUMBER: JG6793 COMPONENT TYPE: FEMORAL COMPONENT, DESCRIPTION: UDI: (B)(4). CATALOG NUMBER:150660005, LOT NUMBER: 3733875, COMPONENT TYPE: TIBIAL BASE COMPONENT, DESCRIPTION: UDI: (B)(4). CATALOG NUMBER: 151710706, LOT NUMBER: 9898466, COMPONENT TYPE: TIBIAL INSERT COMPONENT, DESCRIPTION: UDI: (B)(4). CATALOG NUMBER: 66017750, LOT NUMBER: 61441115, COMPONENT TYPE: CEMENT, DESCRIPTION: UDI: (B)(4).

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 22041081 ↗
• InjuryFeb 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION KNEE DONE IN (B)(6) 2024. IT WAS DISLOCATED AND NEEDED TO BE REVISED FOR STABILITY. THE PATIENT HAD AN ATTUNE REVISION FEMUR WITH SLEEVE AND STEM. THE TIBIA WAS AN ATTUNE REVISION ROTATING PLATFORM WITH SLEEVE AND STEM. THE FEMORAL COMPONENT, FEMORAL SLEEVE AND STEM WERE EXTRACTED AND THE PATIENT WAS CONVERTED TO AN SROM HINGE FEMUR WITH UNIVERSAL SLEEVE AND UNIVERSAL STEM, ALONG WITH A BRIDGING BEARING. THE ATTUNE REVISION TIBIAL TRAY/SLEEVE/STEM CONSTRUCT WAS NOT REVISED. SURGICAL DELAY WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED. DOI: UNKNOWN DOR: (B)(6), 2025 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 21328336 ↗
• InjuryNov 1, 2024Adverse 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 INFECTION OF HARDWARE. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20587527 ↗
• InjurySep 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATE EVENT DESCRIPTION TO CAPTURE TREATMENT/IMPACT: TREATMENT/IMPACT: REQUIRES HOSPITALIZATION, IRRIGATION & DEBRIDEMENT, AND ORAL MEDICATION.

  Patient problems: Unspecified Infection

  MAUDE report 20168971 ↗
• InjuryJun 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT X-RAYS SHOW PROGRESSIVE LUCENT LINES AND CONTINUES TO COMPLAIN OF PAIN. A POLY EXCHANGE WAS PERFORMED ON (B)(6) 2023 AND A DER WAS SUBMITTED. THE FEMORAL COMPONENT WAS REMOVED WITH EASE AND CEMENT HAD NOT ADHERED TO THE BONE. HOWEVER THE FEMORAL SLEEVE WAS INGROWN AND HAD TO REMOVED UTILIZING SIGNIFICANT EFFORT. THE TIBIAL TRAY WAS WELL FIXED, HOWEVER THE TIBIAL SLEEVE ONLY SHOWED FIBROUS TISSUE, INDICATING THAT IT WAS LOOSE. THE PATELLA WAS ALSO REMOVED QUITE EASILY. A FULL REVISION OFF ALL COMPONENTS WAS PREFORMED WITH NO DELAY NOR PATIENT HARM. NO WEAR WAS NOTED AND ALL COMPONENTS WERE APPROPRIATELY SIZED AND ALIGNED. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 19615658 ↗
• InjuryAug 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INCREASED SWELLING OF LEFT KNEE EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE.(B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)

  Patient problems: Swelling/ Edema

  MAUDE report 17488318 ↗
• InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD INFECTED LTKA. SURGEON EXPLANTED THE ATTUNE REVISION IMPLANTS WE IMPLANTED ON (B)(6) 2023. THEY WASHED OUT THE KNEE IMPLANTED JUST A ATTUNE REV FEMORAL COMPONENT AND ATTUNE INSERT ALONG WITH SOME ANTIBIOTIC CEMENT SPACER AND ANTIBIOTIC BEADS. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 17368276 ↗
• InjuryJun 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS FRACTURE OF THE FEMUR WHEN IMPLANTING A LEFT SIZE 7 REVISION ATTUNE KNEE FEMORAL COMPONENT WITH 30MM PARTIALLY COATED SLEEVE AND SIZE 18X60MM PRESSFIT STEM. THERE WAS A SURGICAL DELAY OF 50 MINUTES. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Bone Fracture(s)

  MAUDE report 14841127 ↗
• InjuryJun 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SEPSIS (STREP B) AND LOOSENING OF THE FEMORAL, SLEEVE AND STEM AT THE CEMENT TO BONE INTERFACE. DEPUY CEMENT WAS USED. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2020, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Sepsis

  MAUDE report 14688088 ↗
• InjuryJun 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF IMPLANT. DATE OF IMPLANTATION: (B)(6) 2018. DATE OF REVISION: (B)(6) 2020. (UNKNOWN KNEE) TREATMENT: REMOVAL OF IMPLANT FOR UNKNOWN REASON.

  Patient problems: Unspecified Infection

  MAUDE report 14680475 ↗
• InjuryOct 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INFECTED LEFT TOTAL KNEE ARTHROPLASTY. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018, DATE OF EVENT (ONSET): (B)(6) 2018, (LEFT KNEE). TREATMENT: IV ANTIBIOTICS, SURGICAL I&D WITH REVISION OF ALL FEMORAL CONSTRUCT, TIBIAL CONSTRUCT, INSERT COMPONENTS ON (B)(6) 2018.

  Patient problems: Unspecified Infection

  MAUDE report 12704948 ↗
• InjuryAug 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO REVISION PROCEDURE FOR THIS PATIENT ON (B)(6) 2020. THE PROCEDURE THAT TOOK PLACE FOR THIS PATIENT ON (B)(6) 2020 WAS THE PRIMARY PROCEDURE NOT A REVISION.

  Patient problems: Joint Laxity; Loss of Range of Motion

  MAUDE report 12269312 ↗
• InjuryMay 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS POLY SPIN OUT DUE TO THE GAP BETWEEN THE FEMUR AND TIBIA BEING TOO LARGE. SURGEON IMPLANTED A HINGE WITH THICK TRAY TO CLOSE THE JOINT SPACE. NO SURGICAL DELAY HAS BEEN REPORTED. DOI: (B)(6) 2020. DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11791114 ↗
• InjuryMar 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON REVISED AN ATTUNE REVISION CONSTRUCT. PATIENT WAS DOING FINE FOLLOWING THE FIRST REVISION, BUT HE THEN TORE HIS MCL, WHICH MADE THE KNEE UNSTABLE AND LEAD TO UNEVEN WEAR OF THE POLYETHYLENE. PATIENT HAD SEVERAL FALLS BUT DID NOT RECALL ONE PARTICULAR ONE THAT WAS MORE SEVERE. BUT LIKELY TRAUMATIC. HE WAS ABLE TO KEEP THE TIBIAL COMPONENTS IN PLACE AND IMPLANTED AN SROM HINGED FEMUR WITH AN LPS/ATTUNE REVISION BRIDGING BEARING. SURGEON SAID IT WAS BECAUSE OF AN MCL RUPTURE, WHICH CAUSED INSTABILITY. HE EXTRACTED THE FEMORAL COMPONENT, OFFSET ADAPTER AND PRESS FIT STEM. PLUS THE INSERT.

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

  MAUDE report 11401697 ↗