ATTUNE 1513-04-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10603295475132), received between Oct 5, 2018 and Feb 20, 2026 — classified as 25 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (3 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2026Difficult to Advance

  IT WAS REPORTED DURING A KNEE REPLACEMENT PROCEDURE THAT THE ATTUN REV OFFST STM ADPTR 4MM HAD AN ISSUE WHERE THE NUT, DESIGNED TO ROTATE FREELY, WAS FUSED AT THE TOP OF THE THREADS, PREVENTING NORMAL OPERATION. A SECOND DEVICE FROM THE SAME LOT EXHIBITED THE SAME ISSUE. THE SURGEON USED ADDITIONAL TOOLS TO LOOSEN THE NUT, EVENTUALLY ACHIEVING MOVEMENT, BUT NOT TO THE EXPECTED DEGREE. THIS CAUSED THE STEM TO SHIFT DURING FINAL TORQUING, RESULTING IN FRUSTRATION AND A DELAY OF APPROXIMATELY 30 MINUTES. THE DEVICE WAS ULTIMATELY ASSEMBLED SATISFACTORILY AND IMPLANTED. THERE WAS NO REPORTED PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24400553 ↗
• InjuryMar 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT HAS HAD FIVE PRIOR KNEE REVISION PROCEDURES ON THIS KNEE. DURING THIS PROCEDURE, THE PATIENT'S REVISION COMPONENTS WERE REMOVED DUE TO INFECTION. A STATIC SPACE, MADE OF ANTIBIOTIC BONE CEMENT AND STEINMANN PINS, WERE IMPLANTED TO SPAN THE PATIENT'S KNEE UNTIL HER INFECTION HAS CLEARED. THERE WAS NO SURGERY TIME EXTENDED. DOI: (B)(6) 2023 (FEMORAL COMPONENTS) AND (B)(6) 2024 (TIBIAL COMPONENTS). DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21610614 ↗
• 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: UNK DECEMBER 2020, DATE OF IMPLANT: NO INFORMATION PROVIDED, DATE OF REVISION: ON (B)(6) 2019, DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: INFORMATION NOT PROVIDED.

  Patient problems: Nerve Damage

  MAUDE report 20590663 ↗
• InjuryMay 22, 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 GREAT SAPHENOUS VEIN THROMBUS. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (LEFT KNEE). TREATMENT: ORAL MEDICATION.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19376285 ↗
• InjuryApr 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO SURGICAL DELAY. B. WHAT IS THE AFFECTED SIDE INVOLVED IN THIS EVENT? RIGHT SIDE. C. WAS INSTABILITY RELATED TO POLYETHYLENE WEAR? NO, IT WAS NOT. D. WAS THERE ANY REPORTED MALPOSITION OF COMPONENTS THAT LED TO THE INSTABILITY? NO THERE WAS NOT. E. WERE ANY COMPONENTS UNDERSIZED ON THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? NO, THEY WERE NOT, THE LAXITY IN FLEXION WAS BELIEVED TO BE SOFT TISSUE RELATED. F. WAS THE FEMUR OR TIBIA EXCESSIVELY RESECTED/JOINT LINE RAISED DURING THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? NO, I DON¿T BELIEVE SO AS THE FIRST REVISION ONLY USED AN 8MM POLY.

  Patient problems: Joint Laxity

  MAUDE report 19067483 ↗
• InjuryMar 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE INFECTION WAS CONFIRMED.

  Patient problems: Unspecified Infection

  MAUDE report 18934495 ↗
• MalfunctionOct 11, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT IT TOOK 2 ATTEMPTS TO TIGHTEN THE OFFSET ADAPTOR IMPLANT BUT WAS NOT ABLE TO LOCK. THERE WAS A TEN MINUTE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15581566 ↗
• 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 EVENT: (B)(6) 2021. (RIGHT KNEE). TREATMENT: MANIPULATION UNDER ANESTHESIA.

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

  MAUDE report 15167106 ↗
• 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 15163405 ↗
• 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, 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. AFFECTED SIDE: (RIGHT KNEE). TREATMENT: AWAITING MANIPULATION UNDER ANESTHESIA.

  Patient problems: Loss of Range of Motion

  MAUDE report 14655607 ↗
• InjuryJun 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY: (B)(6). 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 14655600 ↗
• InjuryMay 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INFECTION OF RIGHT (STUDY) KNEE. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT (ONSET): (B)(6) 2021. (RIGHT KNEE). TREATMENT: SURGICAL IRRIGATION & DEBRIDEMENT. ORAL MEDICATION: YES (UNSPECIFIED).

  Patient problems: Unspecified Infection

  MAUDE report 14279979 ↗
• InjuryMar 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR NEUROLOGICAL PAIN NERVUS INFRAPATELLARIS LEFT KNEE. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021, DATE OF EVENT (ONSET): (B)(6) 2022, (LEFT KNEE). TREATMENT: NEURECTOMY NERVUS INFRAPATELLARIS.

  Patient problems: Pain

  MAUDE report 13653213 ↗
• InjuryOct 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR HEMATOMA ON RIGHT KNEE. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021; DATE OF EVENT (ONSET): (B)(6) 2021; (RIGHT KNEE). TREATMENT: SURGICAL EVACUATION OF HEMATOMA AND WOUND IRRIGATION.

  Patient problems: Hematoma

  MAUDE report 12711954 ↗
• 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 12704960 ↗
• InjuryAug 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INFECTION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019, DATE OF EVENT (ONSET): (B)(6) 2021, (RIGHT KNEE). TREATMENT: SURGICAL IRRIGATION AND DEBRIDEMENT.

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

  MAUDE report 12378016 ↗
• MalfunctionAug 17, 2021Device Damaged Prior to Use; Device Damaged Prior to Use

  AFTER TAKING OUT A OFFSET ADAPTER FROM THE BOX, THE STAFF TRIED TO UNLOCK THE NUT FOR THE POSITIONING OF THE TIBIA. BUT THAT IMPLANT DOESN'T WORK AT ALL. AND THEN HE DECIDED TO CHANGE THE PROCESS. AT FIRST, HE ASSEMBLED THE STEM WITH OFFSET ADAPTER. SECOND, HE TRIED TO CHANGE THE OFFSET BUT THE OFFSET ADAPTER WAS STILL LOCKED AND THE STEM WAS ALSO LOCKED AS WELL. UNFORTUNATELY, HE TOOK OUT THE NEW IMPLANT. SURGICAL DELAY OF 20 MINUTES. REPLACEMENT WITH NEW IMPLANT,

  Patient problems: Insufficient Information

  MAUDE report 12334180 ↗
• 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 12324886 ↗
• InjuryJul 14, 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 DEEP VENOUS THROMBOSIS. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021, DATE OF EVENT (ONSET): (B)(6) 2021, (LEFT KNEE). TREATMENT: ORAL MEDICATION (UNSPECIFIED).

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12167594 ↗
• InjuryJun 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR MID TO DISTAL ANTERIOR THIGH PAIN ON (B)(6) 2017, THE PATIENT HAD A REVISED TOTAL RIGHT KNEE TO ADDRESS INSTABILITY. DEPUY COMPONENTS ALONG WITH COMPETITOR CEMENT X2, WERE IMPLANTED DURING THIS PROCEDURE.. (B)(6) 2019 MEDICAL RECORDS NOTE THAT THE PATIENT PRESENTS WITH PAIN IN RIGHT KNEE AND HIP, WITH BUCKLING AND SWELLING OF THE RIGHT KNEE. LEFT KNEE PAIN DUE TO OA CHANGES (NATURAL KNEE). PATIENT IS DOING PHYSICAL THERAPY. DATE OF IMPLANTATION: (B)(6) 2017. DATE OF EVENT (ONSET): (B)(6) 2018. (RIGHT KNEE). TREATMENT: PHYSICAL THERAPY.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 11992873 ↗
• MalfunctionJun 8, 2021Difficult to Insert; Difficult to Insert

  BOLT OF OFFSET ADAPTOR CAN'T BE LOCKED INTO OFFSET POSITION NO SURGERY DELAY. PROCEDURE SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11958287 ↗
• InjuryMay 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR KNEE INSTABILITY. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2017, DATE OF EVENT (ONSET): (B)(6) 2018, (RIGHT KNEE). TREATMENT: PHYSICAL THERAPY & KNEE BRACE.

  Patient problems: Joint Laxity

  MAUDE report 11885702 ↗
• InjuryDec 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ANEMIA- POST OP IRON SUBSTITUTION. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY NOT RELATED TO BOTH DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF EVENT (ONSET): (B)(6) 2020, (RIGHT KNEE). TREATMENT: INJECTED MEDICATION (UNSPECIFIED).

  Patient problems: Anemia

  MAUDE report 10924714 ↗
• 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 10664823 ↗
• InjuryJul 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PAIN AND GIVING WAY OF STUDY KNEE WHILE WALKING LONGER DISTANCES. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. THERE IS A REMOTE POSSIBILITY THAT THE EVENT IS RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018, DATE OF EVENT (ONSET): (B)(6) 2019, (RIGHT KNEE). TREATMENT: INVASIVE KNEE ASPIRATION AND PHYSICAL THERAPY.

  Patient problems: No Code Available; Pain

  MAUDE report 10299970 ↗