ATTUNE 1513-10-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10603295043485), received between Oct 22, 2019 and Apr 30, 2026 — classified as 23 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• 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 25042582 ↗
• InjuryAug 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A COMPLEX PRIMARY TOTAL KNEE REPLACEMENT ON (B)(6) 2025 USING A PRIMARY ATTUNE PS FEMUR, ATTUNE PS ROTATING PLATFORM INSERT, ATTUNE REVISION ROTATING PLATFORM TIBIAL TRAY WITH ATTUNE REVISION TIBIAL SLEEVE AND ATTUNE REVISION PRESSFIT STEM. THE PATIENT HAD A PREVIOUS TIBIAL PLATEAU FRACTURE THAT HAD BEEN REPAIRED USING PLATES AND SCREWS, WHICH HAD SUBSEQUENTLY BEEN REMOVED PRIOR TO THE TOTAL KNEE REPLACEMENT SURGERY. AT THE TIME OF THE TKR SURGERY, NO CONCERNS WERE NOTED. POST-SURGERY, THE PATIENT¿S MEDIAL COLLATERAL LIGAMENT APPEARS TO HAVE FAILED (THIS OCCURRED 2 DAYS POST-OP ON (B)(6) 2025), RESULTING IN THE KNEE BEING IN SEVERE VALGUS AND X-RAY INDICATING THAT THE POLY INSERT WAS NOW ROTATED OUT OF ITS INITIAL POSITION. THE KNEE WAS SUBSEQUENTLY PLACED IN A RANGE OF MOTION BRACE AND FOLLOW-UP X-RAYS SHOWED THE KNEE TO BE IN GOOD ALIGNMENT IN BOTH THE AP AND LATERAL VIEWS. AT THIS STAGE, NO FURTHER ACTION IS PLANNED BUT THE PATIENT WILL BE REVIEWED IN A COUPLE OF WEEKS.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 22895459 ↗
• InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR WOUND HEALING DELAY DEVICE AND PROCEDURE(RELATEDNESS): DEVICE RELATED: DEFINITELY NOT PROCEDURE RELATED: DEFINITELY. DATE OF EVENT: 22 NOV 2018. DATE OF IMPLANT: (B)(6) 2018. DATE OF REVISION: NO INFORMATION PROVIDED DEVICE LOCATION: RIGHT TREATMENT/IMPACT: IRRIGATION & DEBRIDEMENT, INJECTED MEDICATION.

  Patient problems: Impaired Healing

  MAUDE report 20461641 ↗
• InjuryFeb 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED AN ATTUNE REVISION OPERATION TO REMEDY AN INFECTED PRIMARY CONSTRUCT (ZIMMER). THE ATTUNE REVISION CONSTRUCT HAS CAUSED THE PATIENT ISSUES SINCE SOON AFTER THE REVISION OPERATION. TODAY THE ATTUNE REVISION IMPLANTS WERE REMOVED DUE TO CONTINUED INFECTION ISSUES

  Patient problems: Unspecified Infection

  MAUDE report 18713449 ↗
• InjuryFeb 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED AN ATTUNE REVISION OPERATION TO REMEDY AN INFECTED PRIMARY CONSTRUCT (ZIMMER). THE ATTUNE REVISION CONSTRUCT HAS CAUSED THE PATIENT ISSUES SINCE SOON AFTER THE REVISION OPERATION. TODAY THE ATTUNE REVISION IMPLANTS WERE REMOVED DUE TO CONTINUED INFECTION ISSUES.

  Patient problems: Unspecified Infection

  MAUDE report 18711819 ↗
• InjuryNov 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR KNEE PAIN. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2020. DATE OF EVENT: 16 MAY 2021 (RIGHT KNEE). TREATMENT: INJECTED MEDICATION, DIAGNOSTIC INVENTION

  Patient problems: Pain

  MAUDE report 18209056 ↗
• InjuryAug 9, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  CLINICAL ADVERSE EVENT RECEIVED FOR HEART FAILURE. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: ON (B)(6) 2021. DATE OF EVENT: ON (B)(6) 2021. (RIGHT KNEE). TREATMENT: DIAGNOSTIC INTERVENTION COMPLAINT NUMBER: (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 17488478 ↗
• InjuryAug 9, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  CLINICAL ADVERSE EVENT RECEIVED FOR RIGHT KNEE PAIN. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2021. DATE OF EVENT: (B)(6) 2021. (RIGHT KNEE). TREATMENT: ORAL MEDICATION AND PHYSICAL THERAPY COMPLAINT NUMBER: (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

  Patient problems: Pain

  MAUDE report 17488471 ↗
• InjuryDec 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE PAIN (NON-PERSISTENT). 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: NONE.

  Patient problems: Pain

  MAUDE report 16062996 ↗
• InjuryNov 28, 2022Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO FEMORAL SLEEVE AND TIBIAL SLEEVE BEING LOOSE AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15870825 ↗
• InjuryAug 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PATCH OF SYNOVITIS LATERAL ASPECT OF LEFT KNEE. 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) 2018, DATE OF EVENT: (B)(6) 2021, (LEFT KNEE). TREATMENT: INJECTED MEDICATION; DIAGNOSTIC INTERVENTION.

  Patient problems: Synovitis

  MAUDE report 15198743 ↗
• InjuryJul 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR RIGHT ANKLE PAIN 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) 2019. DATE OF EVENT: (B)(6) 2022. RIGHT KNEE. TREATMENT: INJECTED MEDICATION.

  Patient problems: Pain

  MAUDE report 15012671 ↗
• InjuryNov 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PATCH OF SYNOVITIS LATERAL ASPECT OF LEFT KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS NOT RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2018, DATE OF EVENT: (B)(6) 2021, (LEFT KNEE) . TREATMENT: UNSPECIFIED INJECTED MEDICATION AND DIAGNOSTIC INTERVENTION.

  Patient problems: Synovitis

  MAUDE report 12786733 ↗
• InjuryJul 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR POST-OPERATIVE ANEMIA. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2021, DATE OF EVENT: (B)(6) 2021, (LEFT KNEE). TREATMENT: BLOOD TRANSFUSION.

  Patient problems: Anemia

  MAUDE report 12234481 ↗
• InjuryJun 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR SUPERFICIAL WOUND INFECTION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. THERE IS A REMOTE POSSIBILITY THAT THE EVENT IS POSSIBLY 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: INJECTED MEDICATION (UNSPECIFIED), ORAL MEDICATION (UNSPECIFIED)

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

  MAUDE report 12041402 ↗
• InjuryApr 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LOW BACK PAIN EVENT IS SERIOUS AND IS CONSIDERED MODERATE THERE IS A REMOTE POSSIBILITY THAT THE ADVERSE EVENT IS RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018 DATE OF EVENT (ONSET): (B)(6) 2019 (LEFT KNEE). TREATMENT: RADIATION.

  Patient problems: Pain

  MAUDE report 11744543 ↗
• InjuryApr 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LEFT ACHILLES TENDON RUPTURE. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. THERE IS A REMOTE POSSIBILITY THAT THE ADVERSE EVENT IS RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018. DATE OF EVENT (ONSET): (B)(6) 2020. (LEFT KNEE). TREATMENT: SURGICAL PROCEDURE (UNSPECIFIED, BUT NO PRODUCTS REVISED).

  Patient problems: Muscle/Tendon Damage

  MAUDE report 11659755 ↗
• InjuryApr 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR RIGHT KNEE STIFFNESS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019, DATE OF EVENT (ONSET): (B)(6) 2019, (RIGHT KNEE). TREATMENT: SURGICAL INTERVENTION - MANIPULATION OF RIGHT KNEE UNDER ANESTHESIA.

  Patient problems: Muscular Rigidity

  MAUDE report 11633692 ↗
• InjuryApr 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR RIGHT KNEE PAIN. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019, DATE OF EVENT (ONSET): (B)(6) 2020, (RIGHT KNEE). TREATMENT: ARTHROSCOPY OF RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 11633541 ↗
• MalfunctionFeb 11, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE STEM WOULD NOT THREAD INTO TIBIAL COMPONENT. DID NOT DELAY SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11314091 ↗
• InjuryOct 27, 2020Inadequacy of Device Shape and/or Size; Difficult to Advance; Inadequacy of Device Shape and/or Size; Difficult to Advance

  A. WAS ATUNE PRESSFIT STR STEM10X60MM ON THE FEMORAL SIDE? YES IT WAS ON THE FEMORAL SIDE.

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

  MAUDE report 10742547 ↗
• InjuryApr 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REMOVAL OF ATTUNE REVISION, PATIENT REQUIRED ALL IMPLANTS REMOVED DUE TO INSTABILITY AND INFECTION (NO COLLATERAL LIGAMENTS) FROM REVISION (B)(4), (B)(6) 2020 FROM A POLY EXCHANGE DUE TO INSTABILITY.

  Patient problems: Joint Dislocation; Joint Disorder; No Code Available; Unspecified Infection

  MAUDE report 9942972 ↗
• InjuryMar 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF ATTUNE REVISION KNEE DUE TO INFECTION. PRIMARY SURGEON PROF. (B)(6). FEMALE PATIENT ID: (B)(6). IMPLANTS STILL IMPLANTED: 1 X 151820038 ATTUNE MEDIAL DOME PAT 38MM - LOT 9268987. 1 X 151314060 ATUNE PRESSFIT STR STEM14X60MM - LOT J1946P. DID THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION? --> UNKNOWN, DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? --> UNKNOWN, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? --> UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9847671 ↗
• InjuryOct 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR WOUND HEALING DELAY. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS THERE IS A REMOTE POSSIBILITY IT IS RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018; DATE OF EVENT: (B)(6) 2018; (RIGHT KNEE).

  Patient problems: No Code Available

  MAUDE report 9218900 ↗