ATTUNE 1512-14-050Recalls & reported problems

Summary

The FDA's MAUDE database contains 106 adverse event reports that list this exact device (DI 10603295475163), received between Jan 25, 2018 and Sep 30, 2026 — classified as 105 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (7 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 106 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient was infected, doctor removed all components. Affected side: Left.

  Patient problems: Unspecified Infection

  MAUDE report 50947288 ↗
• 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 24871195 ↗
• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. AND ALL COMPONENTS AND CEMENT WERE REMOVED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24582549 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO PAIN AND INSTABILITY IN THE RIGHT KNEE. BOTH THE LATERAL COLLATERAL LIGAMENT (LCL) AND MEDIAL COLLATERAL LIGAMENT (MCL) HAD BEEN SURGICALLY REPAIRED PREVIOUSLY. DOI-(B)(6) 2023, DOR-(B)(6) 2026, AFFECTED SIDE-RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 24532613 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6) STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR ACUTE PAIN OF LEFT KNEE - PRIMARY CHRONIC PAIN OF RIGHT KNEE, OSTEOARTHRITIS OF RIGHT KNEE, ACUTE PAIN OF LEFT KNEE. DEVICE AND PROCEDURE (RELATEDNESS) DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: 13 OCT 2022 DATE OF IMPLANT: (B)(6) 2017 DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: LEFT TREATMENT/IMPACT: INJECTED MEDICATION: YES

  Patient problems: Pain

  MAUDE report 24459454 ↗
• InjuryFeb 24, 2026Loss of or Failure to Bond; No Apparent Adverse Event

  SUBJECT ID: (B)(6) STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ ASEPTIC LOOSENING DEVICE AND PROCEDURE (RELATEDNESS) DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: 26 JAN 2026, DATE OF IMPLANT: (B)(6) 2008, DATE OF REVISION: (B)(6) 2026, DEVICE LOCATION: LEFT. TREATMENT/IMPACT: KNEE REPLACEMENT; WERE DEPUY SYNTHES COMPONENTS REMOVED? YES, COMPONENTS REMOVED (FEMORAL, INSERT, TIBIAL. DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 150440108 LOT NUMBER: MC4462 COMPONENT TYPE: FEMORAL DESCRIPTION: ATTUNE REVISION CRS FEMORAL SIZE 8 LEFT CEMENTED. CATALOG NUMBER: 150660006 LOT NUMBER: 4986915 COMPONENT TYPE: TIBIAL DESCRIPTION: ATTUNE REVISION TIBIAL BASE ROTATING PLATFORM SIZE 6 CEMENTED. CATALOG NUMBER: 151710810 LOT NUMBER: 9927060 COMPONENT TYPE: INSERT DESCRIPTION: ATTUNE REVISION CRS ROTATING PLATFORM INSERT SIZE 8 10MM. CATALOG NUMBER: 151214050 LOT NUMBER: D25093258 COMPONENT TYPE: STEM DESCRIPTION: ATTUNE REVISION CEMENTED STEM 14 MM X 50 MM. CATALOG NUMBER: 545050501 LOT NUMBER: 4989849 COMPONENT TYPE: CEMENT DESCRIPTION: SMARTSET CEMENT WITH GENTAMICIN 40G. CATALOG NUMBER: 151111203 LOT NUMBER: MC6963 COMP

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

  MAUDE report 24430810 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO THE REMOVAL OF IMPLANTS FOR INFECTION. DOI: (B)(6) 2025, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24327411 ↗
• InjuryDec 22, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT ATTUNE CRS FEMORAL RT SZ 5 CEM, ATUNE PRESSFIT STR STEM12X60MM, ATTUNE CEMENTED STEM 14X50MM, ATTUNE CRS RP INSRT SZ 5 6MM, ATUNE REV RP TIB BASE SZ 4 CEM, ATUN TIB SLV M/L 29MM HALF POR, AND ATTUNE MEDIAL ANAT PAT 32MM WERE INVOLVED IN A REPORTED EVENT. THE EVENT CONCERNED A REVISION OF A PREVIOUS ATTUNE REVISION PROCEDURE, WITH THE REASON FOR REVISION BEING INFECTION. THE SURGEON SUSPECTED INFECTION AT THE TIME OF IMPLANTATION DUE TO POOR INGROWTH IN THE TIBIAL SLEEVE, AND NOTED THAT THE CEMENTED FEMORAL STEM WAS EASILY REMOVED. THE EVENT WAS ASSOCIATED WITH THE RIGHT SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 23862787 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD AN INFECTION. SURGEON REMOVED IMPLANTS AND PLACED AN ANTIBIOTIC SPACER. DOI: (B)(6) 2024 , DOR: (B)(6) 2025 , AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22968128 ↗
• InjuryJul 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTS IN OFFICE POST FALL ROUGHLY 6 WEEKS PRIOR POST TOTAL KNEE. SHE NOW COMPLAINS OF PAIN AND INSTABILITY. PHYSICAL EXAM LED SURGEON TO BELIEVE SHE HAD RUPTURED HER MCL AT THE TIME OF FALL AND SHE IS SCHEDULED FOR A REVISION TO ADDRESS. PATIENT HAD BEEN DOING WELL PRIOR TO THE STATED FALL AND WAS VERY HAPPY WITH HER KNEE PRIOR TO THE FALL. PATIENT IS MORBIDLY OBESE AND IS CONSIDERED A CONTRIBUTING FACTOR. DURING SURGERY, THE MCL WAS CONFIRMED TO BE DEFICIENT, ESPECIALLY AT HER SIZE, AND WELL FIXED AND WELL ALIGNED COMPONENTS WERE REMOVED AND A HINGED KNEE CONSTRUCT WAS PLACED WITH NO DELAY NOR PATIENT HARM. NO ALLEGATIONS WERE MADE AGAINST ANY COMPONENT. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Joint Laxity; Pain

  MAUDE report 22565864 ↗
• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THEY USED DEPUY CEMENT BUT IT'S NOT MARKED IN THE CHART AS TO WHICH SURGERY THE CEMENT WAS FOR SO THEY HAVE NO INFORMATION REGARDING CEMENT NUMBERS. DOI: (B)(6) 2021. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22384606 ↗
• InjuryJun 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT TORE HIS MCL AND REQUIRED A HINGE. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22356490 ↗
• InjuryApr 22, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE SURGEON PERFORMED A REVISION OF AN ATTUNE REVISION CONSTRUCT WHICH WAS IMPLANTED ON THE RIGHT SIDE. REASON FOR REVISION WAS DUE TO FEMORAL LOOSENING. THE SURGEON NOTED RADIOLUCENT LINES AROUND THE CEMENTED STEM ON THE FEMORAL COMPONENT. SURGEON USED CMW1. THE SURGEON POINTED OUT THAT CEMENT HAD EXTRUDED PAST THE CEMENT RESTRICTORS (WHICH HE IMPLANTED TWO OF) RESULTING IN AN INADEQUATE CEMENT MANTLE AROUND THE STEM AND PRESSURISATION INTO THE BONE. THE SURGEON ALSO MENTIONED THAT THE PATIENT HAS A PRIMARY KNEE ORIGINALLY WHICH BECAME LOOSE. ALL COMPONENTS WERE REMOVED. THE TIBIA WAS NOT LOOSE AND THE TIBIAL SLEEVE HAD EXCELLENT BIOLOGICAL FIXATION, BUT WAS REVISED AS PARTIAL REVISIONS DON¿T DO AS WELL. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY.

  Patient problems: Insufficient Information

  MAUDE report 21882410 ↗
• InjuryMar 7, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  SUBJECT ID: (B)(6). STUDY NO: OASIS PROD. CLINICAL ADVERSE EVENT RECEIVED FOR ASEPTIC LOOSENING. DATE OF IMPLANT: (B)(6) 2018. DATE OF REVISION: (B)(6) 2025. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: REVISION.

  Patient problems: Insufficient Information

  MAUDE report 21549059 ↗
• InjuryFeb 19, 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 KNEE INFECTION . COMPONENTS WERE REMOVED AND REPLACED WITH ANTIBIOTIC SPACER. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21409926 ↗
• InjuryFeb 19, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT A RIGHT KNEE COMPLETE SECOND REVISION WAS PERFORMED DUE TO FEMORAL AND TIBIAL LOOSENING AT THE CEMENT/IMPLANT INTERFACE. PATIENT EXPERIENCED PAIN AND REQUIRED HARDWARE REMOVAL DUE TO LOOSENING. CEMENT NOT FROM DEPUY.

  Patient problems: Pain

  MAUDE report 21409672 ↗
• InjuryFeb 3, 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 EVENTS RECEIVED FOR FOLLOWING A PERIOD OF EXTENDED CROUCHING, HAS EXPERIENCED A TENDER POINT MID RIGHT SHIN AND A PAINFUL RIGHT KNEE, DEVICE AND PROCEDURE(RELATEDNESS), RELATEDNESS TO DEVICE: POSSIBLY, RELATEDNESS TO PROCEDURE: POSSIBLY, DATE OF EVENT: UN OCT 2023, DATE OF IMPLANT: (B)(6) 2020, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: INJECTED MEDICATION.

  Patient problems: Discomfort; Pain

  MAUDE report 21295773 ↗
• InjuryJan 23, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING FEMUR AND TIBIA. PATIENT APPEARED TO HAVE NOT ONLY LOOSE COMPONENTS BUT ALSO DISPLAYED METALOSIS ALL IN KNEE JOINT AND INTO THE BONE. IT APPEARED THIS CAME FROM THE JUNCTION B/N STEM AND FEMUR AND STEM AND TIBIA. BOTH STEMS SEEMED LOOSE AND DIDN'T APPEAR TO BE FULLY TIGHTENED DOWN UPON IMPLANTING. DOI: (B)(6) 2022. DOI: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Foreign Body Reaction

  MAUDE report 21217645 ↗
• InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A UTI ROUGHLY ONE MONTH AGO, AND THE SURGEON BELIEVES IT SEEDED HER TOTAL KNEE AS THE PATIENT HAD BEEN DOING QUITE WELL PRIOR TO THIS EVENT. ALL WELL FIXED, WELL ALIGNED AND WELL FUNCTIONING IMPLANTS WERE REMOVED AND REVISED IN A ONE STAGE REVISION KNEE FOR INFECTION. THERE WAS NO DELAY NOR PATIENT HARM NOTED. NO ALLEGATION WAS MADE AGAINST ANY COMPONENT. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21149570 ↗
• InjuryDec 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT AS PER SURGEON. THE PATIENT HAD NICKEL ALLERGY. SURGEON REMOVED ALL COMPONENTS AND PUT IN COMPETITOR'S NICKEL FREE IMPLANTS. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 20831277 ↗
• InjuryOct 25, 2024Adverse 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 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 20535045 ↗
• InjuryOct 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? -NO. B. WERE THERE ANY DEPUY INSTRUMENTATION THAT BROKE DURING SURGERY? IF YES, PLEASE PROVIDE THE DETAILS -NO.

  Patient problems: Unspecified Infection

  MAUDE report 20492441 ↗
• InjuryOct 17, 2024Adverse 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 RIGHT KNEE ARTHROFIBROSIS. DEVICE AND PROCEDURE(RELATEDNESS): DEVICE RELATED: DEFINITELY NOT. PROCEDURE RELATED: DEFINITELY. DATE OF EVENT: 10 APR 2019. DATE OF IMPLANT: NO INFORMATION PROVIDED. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: : CLOSED REDUCTION/MANIPULATION.

  Patient problems: Adhesion(s)

  MAUDE report 20471438 ↗
• 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: (B)(6) 2018. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: ORAL MEDICATION.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20443825 ↗
• InjurySep 30, 2024Adverse 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 SEPSIS. DEVICE RELATEDNESS: NO INFORMATION PROVIDED. PROCEDURE RELATEDNESS: NO INFORMATION PROVIDED. DATE OF EVENT: UNK DEC 2024. DATE OF IMPLANT: (B)(6) 2019. DATE OF REVISION : NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: INJECTED MEDICATION.

  Patient problems: Sepsis

  MAUDE report 20333253 ↗