ATTUNE 1506-60-005Recalls & reported problems

Summary

The FDA's MAUDE database contains 86 adverse event reports that list this exact device (DI 10603295042891), received between Apr 17, 2019 and Jun 22, 2026 — classified as 82 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (8 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 86 reports, in the reporter's own words as published by the FDA.

• InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6) STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR INFECTION LEFT KNEE DEVICE RELATED: POSSIBLE PROCEDURE RELATED: POSSIBLE DATE OF EVENT: 15 NOV 2021 DATE OF IMPLANT: (B)(6) 2019 DATE OF REVISION: (B)(6) 2021 DEVICE LOCATION: LEFT. TREATMENT/IMPACT: HOSPITALIZATION, REVISION OF STUDY JOINT, COMPONENTS REMOVED (ATTUNE FEMORAL COMPONENT, ATTUNE TIBIAL INSERT, ATTUNE TIBIAL BASE, ATTUNE TIBIAL STEM, ATTUNE TIBIAL SLEEVE)

  Patient problems: Unspecified Infection

  MAUDE report 25579348 ↗
• 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 25042625 ↗
• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. STAGE 1 REMOVAL OF ALL 3 IMPLANTS. NATIVE PATELLA. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24244964 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: OASIS PROD. CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ INFECTION. DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: 29 DEC 2025. DATE OF IMPLANT: (B)(6) 2025. DATE OF REVISION: (B)(6) 2025. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: DEPUY SYNTHES COMPONENTS REMOVED (FEMORAL AND TIBIAL COMPONENTS).

  Patient problems: Unspecified Infection

  MAUDE report 24200716 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POSSIBLE INFECTION OF REVISION RTKA THAT WAS IMPLANTED (B)(6) 2024. REMOVED ALL IMPLANTS AND WASHED OUT AND PERFORMED A 1 1/2. STAGE REVISION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24054820 ↗
• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING ADDITIONAL EVENT INFORMATION WERE REVIEWED: COMPONENTS REMOVED: N/A. ATTUNE FEMORAL COMPONENT: YES; NO. ATTUNE FEMORAL STEM: YES; NO. ATTUNE TIBIAL BASE: YES; NO. ATTUNE TIBIAL INSERT: YES; NO.

  Patient problems: Arthritis; Unspecified Infection

  MAUDE report 24024460 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS TIBIA REVISION FOR REPORT OF PAIN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 23959551 ↗
• InjuryDec 15, 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 BILATERAL LEG CELLULITIS - WORSE ON LEFT LEG DEVICE AND PROCEDURE (RELATEDNESS) , DEVICE RELATED: DEFINITELY NOT , PROCEDURE RELATED: POSSIBLY, DATE OF EVENT: 29 OCT 2025, DATE OF IMPLANT: (B)(6) 2024, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: LEFT. TREATMENT/IMPACT: OUTCOME: ONGOING.

  Patient problems: Cellulitis

  MAUDE report 23810139 ↗
• InjuryDec 10, 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 INFECTED LEFT STUDY KNEE. DEVICE RELATED: DEFINITELY NOT. PROCEDURE RELATED: PROBABLY. TREATMENT/IMPACT: READMISSION ((B)(6) 2025); ARTHROSCOPY. DATE OF EVENT: 29 OCT 2025. DATE OF IMPLANT: (B)(6) 2024. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: HOSPITALIZATION (INITIAL OR PROLONGED): YES; INJECTED MEDICATION: YES. TREATMENT/IMPACT: REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OR DAMAGE: TRUE. DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 150410106. LOT NUMBER: 4315735. COMPONENT TYPE: FEMORAL COMPONENT. DESCRIPTION: ATTUNE P/S FEM LT SZ 6 CEM. CATALOG NUMBER: 150660005. LOT NUMBER: 3733874. COMPONENT TYPE: TIBIAL BASE COMPONENT. DESCRIPTION: ATTUNE REVISION TIBIAL BASE ROTATING PLATFORM SIZE 5 CEMENTED. CATALOG NUMBER: 151650612. LOT NUMBER: 9493237. COMPONENT TYPE: TIBIAL INSERT COMPONENT. DESCRIPTION: ATTUNE PS RP INSRT SZ 6 12MM. CATALOG NUMBER: 151820038. LOT NUMBER: 4304615. COMPONENT TYPE: PATELLA. DESCRIPTION: ATTUNE MEDIAL DOME PAT 38MM. CATALOG NUMBER: 66017569. LOT NUMBER: 67681283. COMPONENT TYPE: CEMENT. DESCRIPTION: PALACOS R+G 2X40.

  Patient problems: Unspecified Infection

  MAUDE report 23767497 ↗
• InjuryDec 10, 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 PAIN, REDNESS AND SWELLING IN STUDY KNEE. DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: 29 OCT 2025. DATE OF IMPLANT: (B)(6) 2024. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: INJECTED MEDICATION. CLINICAL ADVERSE EVENT RECEIVED FOR PAIN, REDNESS AND SWELLING IN STUDY KNEE. DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: DEFINITELY NOT. PROCEDURE RELATED: PROBABLY. TREATMENT: HOSPITALIZATION (INITIAL OR PROLONGED): YES, REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OR DAMAGE: YES, READMISSION: (B)(6) 2025. DEPUY SYNTHES PRODUCTS USED: DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 150410106, LOT NUMBER: 4315735, COMPONENT TYPE: FEMORAL COMPONENT, DESCRIPTION: ATTUNE P/S FEM LT SZ 6 CEM. CATALOG NUMBER: 150660005, LOT NUMBER: 3733874, COMPONENT TYPE: TIBIAL BASE COMPONENT, DESCRIPTION: ATTUNE REVISION TIBIAL BASE ROTATING PLATFORM SIZE 5 CEMENTED. CATALOG NUMBER: 151650612, LOT NUMBER: 9493237, COMPONENT TYPE: TIBIAL INSERT COMPONENT, DESCRIPTION: ATTUNE PS RP INSRT SZ 6 12MM. CATALOG NUMBER: 151820038, LOT N

  Patient problems: Erythema; Pain; Swelling/ Edema

  MAUDE report 23767185 ↗
• InjuryOct 29, 2025Adverse 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 EXPERIENCED EXCESSIVE LAXITY IN EXTENSION AND DEFICIT IN FLEXION ON A TKA WITH ATTUNE FROM 2022. PATIENT EXPERIENCED REDUCED MOBILITY AND PAIN, AND REQUIRED REVISION SURGERY.

  Patient problems: Joint Laxity; Loss of Range of Motion; Pain

  MAUDE report 23413377 ↗
• InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE EXTRACTED DUE TO INFECTION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23404452 ↗
• InjuryOct 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PROGRESSIVE LUCENT LINES AROUND COMPONENTS AND PAIN, SUGGESTING FAILED FIXATION. IMPLANTS WERE REMOVED UNEVENTFULLY AND REIMPLANTED WITH NEW COMPONENTS. FROZEN SECTION WAS NEGATIVE FOR INFECTION. CEMENT HAD NOT ADHERED TO THE BONE, BUT THE TIBIAL SLEEVE WAS WELL FIXED AND THUS LEFT IN PLACE. THE FEMORAL COMPONENTS HAD BEEN REVISED ON (B)(6) 2024 FOR FAILED INGROWTH AND A CEMENTED STEM WAS PLACED AT THAT TIME. POLY WAS REVISED (B)(6) 2024 WHEN EXCESSIVE SCAR TISSUE WAS REMOVED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 23380103 ↗
• 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)(4). 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) 2014. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: 2 X ERYTHROCYTE CONCENTRATE.

  Patient problems: Anemia

  MAUDE report 23368123 ↗
• 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: (B)(6) 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 23357310 ↗
• InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS END-STEM PAIN ON TIBIA. SO IT WAS REVISED TO SHORTER THE STEM. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 23095437 ↗
• InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED. ALL IMPLANTS WERE EXPLANTED AND SPACER WAS IMPLANTED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23075993 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION KNEE. THE PATIENT HAS HAD MILD PAIN SINCE THIS TIME. RECENT ASPIRATION WAS POSITIVE FOR INFECTION WHICH COULD HAVE BEEN PRESENT SINCE THE TIME OF REVISION. A ONE STAGE REVISION WAS PERFORMED AS THE ORGANISM IS SENSITIVE. ALL COMPONENTS WERE WELL FIXED AND WELL ALIGNED AND THE KNEE WAS WELL BALANCED. ALL COMPONENTS WERE REMOVED AND A THOROUGH DEBRIDEMENT WAS PERFORMED. NEW COMPONENTS, ALONG WITH PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS WERE PLACED IN A DUAL SET UP FASHION. NO DELAYS NOR PATIENT HARM WAS NOTED. SURGEON ROUTINELY UTILIZES DEPUY 2 WITH GENT FOR REVISION KNEE REPLACEMENTS. CEMENT IS HAND MIXED IN A BOWL. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 22792057 ↗
• InjuryAug 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q2 OF 2025. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: THE ATTUNE FEMORAL COMPONENT, ATTUNE FEMORAL STEM, AND ATTUNE TIBIAL INSERT WERE REVISED FOR PAIN.

  Patient problems: Pain

  MAUDE report 22716753 ↗
• InjuryJul 30, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q2 OF 2025. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: THE ATTUNE FEMORAL COMPONENT, TIBIAL TRAY, AND TIBIAL SLEEVE WERE REVISED FOR LOOSENING AT AN UNKNOWN INTERFACE AND PAIN.

  Patient problems: Pain

  MAUDE report 22668282 ↗
• InjuryJul 21, 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 INFECTED RIGHT KNEE. SPACER PLACEMENT WAS DONE. NO SURGICAL DELAY WAS REPORTED. AFFECTED SITE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22556570 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAS INFECTED AND ALL COMPONENTS WERE REMOVED AND A SPACER WAS MADE WITH NEW COMPONENTS. HIGH DOSE ANTIBIOTICS WERE PLACED ON COMPONENTS ALONG WITH PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. HICKMAN CATHETERS WERE ALSO PLACED TO PROVIDE ADDITION ANTIBIOTIC TREATMENT POSTOPERATIVELY. NO PATIENT HARM WAS NOTED AND NO DELAY OCCURRED. INITIAL PROCEDURE FEMORAL SIDE COMPONENTS WERE REVISED ON (B)(6) 2024. AN I&D WITH FEMUR AND INSERT EXCHANGE WAS PERFORMED ON (B)(6) 2025 AND (B)(4) WAS SUBMITTED. THERE WAS A LOOSENING REPORTED AT STEM ON BONE TO CEMENT INTERFACE. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE : RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22372782 ↗
• InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD REVISION FOR INFECTION OF RIGHT REVISION TOTAL KNEE. THE KNEE WAS VERY INFECTED, AND ALL OF THE COMPONENTS CAME OUT WITH MINIMAL EFFORT. NO SPECIFIC COMPONENT WAS GROSSLY LOOSE. DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22105309 ↗
• 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 22041082 ↗
• InjuryFeb 3, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT HAD A LEFT TOTAL KNEE REVISION DONE IN 2021. THE TIBIAL COMPONENTS BECAME LOOSE AND THE PATIENT WAS BROUGHT IN FOR TIBIAL COMPONENTS REVISION. THERE WAS NO DELAY IN SURGERY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21294390 ↗