ATTUNE 1549-08-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10603295383123), received between Oct 16, 2019 and Nov 3, 2025 — classified as 20 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (4 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryNov 3, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ ASEPTIC LOOSENING DATE OF EVENT: (B)(6) 2025. DATE OF REVISION: (B)(6) 2025. TREATMENT/IMPACT: REVISION, COMPONENTS REMOVED (FEMORAL, INSERT, TIBIAL), SYNOVECTOMY

  Patient problems: Insufficient Information

  MAUDE report 23452865 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE EMERGENCY ROOM IN (B)(6) WITH BILATERAL INFECTED KNEES FROM AN ACUTE INFECTION IN THE PATIENTS BLOOD. IT AFFECTED BOTH THE KNEES WHICH HAD REV IMPLANTS IN AND BOTH THE SHOULDERS WHICH HAD NO IMPLANTS. PATIENT WAS WASHED OUT AND IMPLANT EXCHANGES TOOK PLACE ON 2 SEPARATE OCCASIONS AT A DIFFERENT FACILITY. DERS WERE SUBMITTED. PATIENT CAME INTO CLINIC FOR FOLLOW UP ON (B)(6) 2025 AND BOTH KNEES APPEARED TO STILL BE INFECTED. CULTURES SHOWED A SENSITIVE STREP. SURGEON ADMITTED THE PATIENT AND BILATERAL KNEE REVISIONS WERE PERFORMED IN A ONE STAGE FASHION TO INCLUDE THOROUGH IRRIGATION AND DEBRIDEMENT AND PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. THERE WAS NO DELAY NOR PATIENT HARM NOTED. NO ALLEGATIONS WERE MADE AGAINST ANY COMPONENT AS THIS WAS FROM AN ORGANISM IN PATIENT BLOOD THAT AFFECTED MULTIPLE JOINTS IN PATIENT'S BODY. DATE OF IMPLANTATIONS: RIGHT REVISION KNEE WAS (B)(6) 2016. LEFT REVISION KNEE WAS (B)(6) 2023. ON (B)(6) 2025, AN I&D AND INSERT EXCHANGE TOOK PLACE FOR THE LEFT KNEE FOR HEMATOMAS, AND POSSIBLE INFECTION (NOT CONFIRMED AT THAT TIME) AT (B)(6) MEDICAL CENTER. CAPTURED IN (B)(4). AT THE SAME TIME, ON (B)(6) 2025,

  Patient problems: Unspecified Infection

  MAUDE report 21884413 ↗
• 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 21882416 ↗
• 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 20831301 ↗
• 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 20831298 ↗
• InjurySep 20, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT CAME BACK IN TO SEE DOCTOR WITH REDNESS (HOTNESS) AND PAIN IN PATIENT'S RTK. AFTER TESTING THEY DETERMINED THE KNEE TO BE SEPTIC AND A REVISION WAS NEEDED. UPON OPENING THE JOINT THE COMPONENTS APPEARED TO BE LOOSE AND THERE WAS BONE LOSS BETWEEN THE CEMENT MANTLE AND THE BONE. THE COMPONENTS WERE REMOVED, THE JOINT WAS THOROUGHLY IRRIGATED AND THE CANALS WERE REAMED OUT. AFTERWARDS NEW REVISION COMPONENTS WERE PLACED WITH ANTIBIOTIC CEMENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. DOI: (B)(6) 2022, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Erythema; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 20267196 ↗
• InjurySep 20, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT CAME BACK IN TO SEE DOCTOR WITH REDNESS (HOTNESS) AND PAIN IN PATIENT'S RTK. AFTER TESTING THEY DETERMINED THE KNEE TO BE SEPTIC AND A REVISION WAS NEEDED. UPON OPENING THE JOINT THE COMPONENTS APPEARED TO BE LOOSE AND THERE WAS BONE LOSS BETWEEN THE CEMENT MANTLE AND THE BONE. THE COMPONENTS WERE REMOVED, THE JOINT WAS THOROUGHLY IRRIGATED AND THE CANALS WERE REAMED OUT. AFTERWARDS NEW REVISION COMPONENTS WERE PLACED WITH ANTIBIOTIC CEMENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. DOI: (B)(6) 2022, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Erythema; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 20267194 ↗
• InjurySep 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE STIFFNESS. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2018; DATE OF EVENT: (B)(6) 2021; (LEFT KNEE). TREATMENT: PHYSICAL THERAPY.

  Patient problems: Muscular Rigidity

  MAUDE report 17773156 ↗
• InjuryDec 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR KNEE STIFFNESS (ONGOING). EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018, DATE OF EVENT (ONSET): (B)(6) 2019, (LEFT KNEE). TREATMENT: KNEE MANIPULATION UNDER ANESTHESIA.

  Patient problems: Muscular Rigidity

  MAUDE report 12975441 ↗
• InjuryOct 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED INDICATED THAT THE PRIMARY OPERATIVE NOTES AND THE FIRST REVISION PROCEDURE NOTES WERE NOT PROVIDED WITHIN THIS SET OF MEDICAL RECORDS. IT IS UNKNOWN, AT THIS TIME, WHAT THE MANUFACTURER OF THE PRIMARY IMPLANTS OR FIRST REVISION SURGERY WERE. UNKNOWN IF DEPUY ¿ DATES OF PRIMARY AND FIRST REVISION SURGERIES ALSO NOT PROVIDED. REVISION OPERATIVE NOTES (B)(6) 2019 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REVISION DUE TO INFECTION. IT IS UNKNOWN IF DEPUY PRODUCTS WERE IMPLANTED AT THIS SURGERY. RE-IMPLANTATION OPERATIVE NOTES (B)(6) 2019 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE RE-IMPLANTATION DUE TO INFECTION MARKERS WERE SATISFACTORY FOR RE-IMPLANTATION. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. REVISION OPERATIVE NOTES (B)(6) 2021 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REVISION DUE TO INFECTION. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. ((B)(4)). REVISION OPERATIVE NOTES (B)(6) 2021 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REVISION DUE TO PAIN, SWELLING AND HEMATOGENOUS SPREAD OF INFECTION. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SU

  Patient problems: Unspecified Infection

  MAUDE report 12705675 ↗
• InjuryOct 25, 2021Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  CLINICAL ADVERSE EVENT RECEIVED FOR PAIN AND INSTABILITY, SUBJECTIVELY WORSE ON STAIRS WEAKNESS SUPPORTING KNEE AND HIP MUSCLES. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE THERE IS A REMOTE POSSIBILITY THE EVENT IS RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020. DATE OF EVENT (ONSET): (B)(6) 2021. TREATMENT: PHYSICAL THERAPY.

  Patient problems: Fatigue; Joint Laxity; Pain

  MAUDE report 12691090 ↗
• InjuryOct 25, 2021Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  CLINICAL ADVERSE EVENT RECEIVED FOR PAIN AND INSTABILITY, SUBJECTIVELY WORSE ON STAIRS WEAKNESS SUPPORTING KNEE AND HIP MUSCLES. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE THERE IS A REMOTE POSSIBILITY THE EVENT IS RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020. DATE OF EVENT (ONSET): (B)(6) 2021. (RIGHT KNEE). TREATMENT: PHYSICAL THERAPY.

  Patient problems: Fatigue; Joint Laxity; Pain

  MAUDE report 12691044 ↗
• InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4). THE PATIENT WAS REVISED DUE TO INFECTION. EVERYTHING WAS REMOVED AND STAGE ONE SPACER IMPLANTED. NO LOOSENING AND SURGICAL DELAY NOTED. DOI: (B)(6) 2019. DOR: (B)(6) [201]. LEFT KNEE.

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

  MAUDE report 12438713 ↗
• InjuryAug 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. ALL COMPONENTS WERE EXTRACTED AND A TEMPORARY ABX SPACER WAS PLACED. UNKNOWN BONE CEMENT WAS USED. NO SURGICAL DELAY. DOI: (B)(6) 2019; DOR: (B)(6) 2021; RIGHT KNEE.

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

  MAUDE report 12324894 ↗
• InjuryOct 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR DISTAL FEMUR BONE FRACTURE, RIGHT EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF EVENT (ONSET): (B)(6) 2020, (RIGHT KNEE). TREATMENT: OPEN REDUCTION INTERNAL FIXATION.

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

  MAUDE report 10711498 ↗
• InjuryOct 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR DISTAL FEMUR BONE FRACTURE, RIGHT EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF EVENT (ONSET): (B)(6) 2020, (RIGHT KNEE). TREATMENT: OPEN REDUCTION INTERNAL FIXATION.

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

  MAUDE report 10711489 ↗
• InjuryApr 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING ATTUNE REVISION KNEE, THE RIGHT SIDE OF BILATERAL REVISION KNEE WAS FRACTURED UPON IMPLANTATION OF THE FEMORAL COMPONENT. THE FRACTURE WAS OF THE ENTIRE MEDIAL CONDYLE EXTENDING UP THE DISTAL FEMUR INTO THE METAPHYSEAL/DIAPHYSEAL JUNCTION. THE FEMORAL AND THEN TIBIAL COMPONENTS WERE REMOVED SINCE THE CROSS OVER POLY HAS YET TO BE RELEASED TO THE FIELD. THERE WAS A COMMENT MADE THAT IT WOULD HAVE SURE BE NICE NOT TO HAVE TO REMOVE THE TIBIA TO CONVERT TO A DISTAL FEMORAL REPLACEMENT. AN HOUR AND HALF OF SURGICAL DELAY WAS NOTED. DOE: (B)(6) 2020.

  Patient problems: Bone Fracture(s); No Code Available; Not Applicable

  MAUDE report 9938339 ↗
• InjuryApr 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING ATTUNE REVISION KNEE, THE RIGHT SIDE OF BILATERAL REVISION KNEE WAS FRACTURED UPON IMPLANTATION OF THE FEMORAL COMPONENT. THE FRACTURE WAS OF THE ENTIRE MEDIAL CONDYLE EXTENDING UP THE DISTAL FEMUR INTO THE METAPHYSEAL/DIAPHYSEAL JUNCTION. THE FEMORAL AND THEN TIBIAL COMPONENTS WERE REMOVED SINCE THE CROSS OVER POLY HAS YET TO BE RELEASED TO THE FIELD. THERE WAS A COMMENT MADE THAT IT WOULD HAVE SURE BE NICE NOT TO HAVE TO REMOVE THE TIBIA TO CONVERT TO A DISTAL FEMORAL REPLACEMENT. AN HOUR AND HALF OF SURGICAL DELAY WAS NOTED. DOE: (B)(6) 2020.

  Patient problems: Bone Fracture(s); No Code Available; Not Applicable

  MAUDE report 9938265 ↗
• InjuryDec 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WE HAVE TODAY EXTRACTED AN ATTUNE REVISION CONSTRUCT, DUE TO INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9505245 ↗
• InjuryOct 16, 2019Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  CLINICAL ADVERSE EVENT RECEIVED FOR FLEXION LIMITATION OF THE LEFT KNEE AND PAIN IN FRONT OF THE LEFT KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE AND PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019; DATE OF EVENT: (B)(6) 2019; (LEFT KNEE).

  Patient problems: Limited Mobility Of The Implanted Joint; Muscular Rigidity; Pain

  MAUDE report 9199202 ↗