ATTUNE 1549-07-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10603295383109), received between Jun 12, 2019 and Jul 27, 2026 — classified as 28 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 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 50039684 ↗
• 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 25042378 ↗
• InjuryMar 31, 2026Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO TIBIA AND FEMUR LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. DOI: (B)(6) 2023, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 24747410 ↗
• InjuryNov 1, 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 ENTRAPMENT RAMUS INFRAPATELLARIS DEVICE AND PROCEDURE (RELATEDNESS): REMOTE POSSIBILITY RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. DATE OF EVENT: (B)(6) 2020. DATE OF IMPLANT: NO INFORMATION PROVIDED. DATE OF REVISION: (B)(6) 2019. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: INFORMATION NOT PROVIDED.

  Patient problems: Nerve Damage

  MAUDE report 20590597 ↗
• 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 20587539 ↗
• 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 20587520 ↗
• 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 17488378 ↗
• 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 17488306 ↗
• InjuryJan 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SEPTIC LOOSENING OF FEMORAL COMPONENT AT THE BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. SURGEON EXPLANTED FEMUR AND REVISED WITH TEMPORARY SPACER. DOI- (B)(6) 2021. DOR- (B)(6) 2023. AFFECTED SIDE- UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16184512 ↗
• InjuryJan 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SEPTIC LOOSENING OF FEMORAL COMPONENT AT THE BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. SURGEON EXPLANTED FEMUR AND REVISED WITH TEMPORARY SPACER. DOI- (B)(6) 2021. DOR- (B)(6) 2023. AFFECTED SIDE- UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16184331 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE PAIN. 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) 2022 (LEFT KNEE). TREATMENT: INJECTED MEDICATION (CORTISONE).

  Patient problems: Pain

  MAUDE report 15966211 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE PAIN. 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) 2022; (LEFT KNEE). TREATMENT: INJECTED MEDICATION (CORTISONE).

  Patient problems: Pain

  MAUDE report 15966206 ↗
• InjuryAug 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR KNEE ARTHROFIBROSIS AND LIMITED RANGE OF MOTION. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: DATE OF EVENT: UNK (B)(6) 2021 (RIGHT KNEE). TREATMENT: MANIPULATION UNDER ANESTHESIA.

  Patient problems: Adhesion(s); Loss of Range of Motion

  MAUDE report 15182204 ↗
• InjuryAug 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR KNEE ARTHROFIBROSIS AND LIMITED RANGE OF MOTION. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT:, DATE OF EVENT: (B)(6) 2021, (RIGHT KNEE). TREATMENT: MANIPULATION UNDER ANESTHESIA.

  Patient problems: Adhesion(s); Loss of Range of Motion

  MAUDE report 15163201 ↗
• 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 14841133 ↗
• 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 14841124 ↗
• InjuryJun 24, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  CLINICAL ADVERSE EVENT RECEIVED FOR REVISION OF TOTAL KNEE TO ADDRESS LOOSE FEMUR EVENT IS SERIOUS AND IS CONSIDERED MODERATE EVENT IS DEFINITELY RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019, DATE OF EVENT (ONSET): 03/01/2022. (RIGHT KNEE). TREATMENT: REVISION OF FEMORAL CONSTRUCT.

  Patient problems: Insufficient Information

  MAUDE report 14799616 ↗
• InjuryJun 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY: DSJ-2016-02 NEW CLINICAL ADVERSE EVENT RECEIVED FOR RIGHT KNEE LIMITED RANGE OF MOTION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2021. DATE OF EVENT: UNK (B)(6)2021. AFFECT SIDE: (RIGHT KNEE). TREATMENT: AWAITING MANIPULATION UNDER ANESTHESIA.

  Patient problems: Loss of Range of Motion

  MAUDE report 14655645 ↗
• InjuryJun 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR RIGHT KNEE LIMITED RANGE OF MOTION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2021, DATE OF EVENT: (B)(6) 2021, (RIGHT KNEE). TREATMENT: AWAITING MANIPULATION UNDER ANESTHESIA.

  Patient problems: Loss of Range of Motion

  MAUDE report 14655590 ↗
• InjuryMar 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAIN AND LOOSENING. IT IS UNKNOWN WHICH PRODUCTS AND INTERFACES WERE LOOSE.

  Patient problems: Pain

  MAUDE report 13791867 ↗
• InjuryFeb 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON THE (B)(6) 2021 THE PATIENT HAD A ATTUNE REVISION REMOVED DUE TO INFECTION. I HAVEN'T BEEN ABLE TO OBTAIN THE PRODUCT LOT NUMBERS THAT WERE IN THE PATIENT. I WILL NEED TO CONTACT THE SURGEON OF THESE AS THE NURSING STAFF AT THE HOSPITAL WERE UNSURE. THE SURGEON PUT AN PALACOS ANTIBIOTIC CEMENT SPACER INTO THE PATIENT. THE IMPLANTS REMOVED: FEMORAL COMPONENT WITH FULLY PORUS SLEEVE AND PRESSFIT STEM, TIBIAL COMPONENT WITH FULLY PORUS SLEEVE, PRESSFIT STEM AND TIBIAL CRS INSERT

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

  MAUDE report 11332895 ↗
• InjuryOct 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAS NOW RECEIVED A NEURECTOMY AS TREATMENT.

  Patient problems: No Code Available

  MAUDE report 10665157 ↗
• InjuryMar 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A REVISION TOTAL KNEE DONE ELSEWHERE. CAME IN WITH INFECTION. ALL COMPONENTS WERE REMOVED AND A STATIC SPACER WAS INSERTED. DOI: (B)(6) 2019, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9853269 ↗
• InjuryMar 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A REVISION TOTAL KNEE DONE ELSEWHERE. CAME IN WITH INFECTION. ALL COMPONENTS WERE REMOVED AND A STATIC SPACER WAS INSERTED. DOI: (B)(6) 2019, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9853264 ↗
• InjuryJan 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN POST RIGHT KNEE REVISION. EXTENSIVE LAB AND ALLERGY TEST WERE DONE WHICH RESULTED IN METAL ALLERGY. ALL IMPLANTS WERE REVISED AND IMPLANTED WITH COMPETITOR IMPLANTS. NO SURGICAL DELAY NOTED. DOI: (B)(6) 2018; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: Hypersensitivity/Allergic reaction; No Code Available; Pain

  MAUDE report 9642321 ↗