ATTUNE 1512-14-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10603295475170), received between Jan 22, 2020 and Sep 4, 2025 — classified as 21 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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 16, 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.

• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO DISTAL FEMORAL FRACTURE. DOI: (B)(6) 2021. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22967140 ↗
• InjuryAug 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ASPIRATED LAST WEEK AND IS NOW GROWING YEAST. ALL COMPONENTS WERE REMOVED IN A ONE STAGE REVISION AND NEW COMPONENTS WERE PLACED AFTER A THOROUGH I&D AND PLACEMENT OF RESORBABLE BEADS CONTAINING ANTIBIOTICS AND AN ANTIFUNGAL AGENT. ALL COMPONENTS WERE FUNCTIONING AS EXPECTED HOWEVER THE FEMORAL SLEEVE HAD FAILED TO INGROW, LIKELY DUE TO THE FUNGUS BEING PRESENT. TIBIAL COMPONENT AND CEMENTED STEM WERE PLACED ON THE ABOVE LISTED DATE. FEMORAL COMPONENTS AND INSERT HAD BEEN REVISED ON (B)(6) 2025 FOR CONTINUED INFECTION. A DER WAS FILED UNDER (B)(4) PER OPTIMIZE. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22748077 ↗
• 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 21295825 ↗
• InjuryJan 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: (B)(6). SUBJECT ID: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR LOWER RESPIRATORY TRACT INFECTION DEVICE AND PROCEDURE (RELATEDNESS): DEVICE RELATED: DEFINITELY NOT. PROCEDURE RELATED: DEFINITELY. DATE OF EVENT: 15-JAN-2022. DATE OF IMPLANT: (B)(6) 2022. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: HOSPITALIZATION/INJECTED MEDICATION/ORAL MEDICATION.

  Patient problems: Unspecified Infection

  MAUDE report 21264249 ↗
• InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). IT WAS REPORTED THAT, CLINICAL ADVERSE EVENT RECEIVED FOR SEVERE POST OPERATIVE PAIN. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: UNKNOWN. DATE OF EVENT (ONSET): 1/13/2022. (UNKNOWN KNEE). TREATMENT: UNSPECIFIED INJECTED MEDICATION, UNSPECIFIED ORAL MEDICATION, AND FEMORAL NERVE BLOCK.

  Patient problems: Pain

  MAUDE report 20544818 ↗
• InjurySep 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A RIGHT KNEE REVISION OCCURRED ON (B)(6) 2024 DUE TO A FRACTURED FEMUR POST INITIAL SURGERY. THE ORIGINAL IMPLANT SURGERY WAS AN UNKNOWN DATE IN 2020. THERE WAS NO SURGICAL DELAY AND NO ADDITIONAL PATIENT CONSEQUENCES.

  Patient problems: Limb Fracture

  MAUDE report 20303157 ↗
• InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS RE-IMPLANTED FOLLOWING THE REMOVAL OF AN ANTIBIOTIC SPACER. PATIENT FELL WHEN THEY GOT HOME THE NEXT DAY CAUSING THE MCL TO BE COMPROMISED. PATIENT WAS BROUGHT BACK FOR SURGERY AND ALL FEMORAL COMPONENTS WERE REMOVED AND A SROM HINGE WAS PLACED. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024, DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Unspecified Tissue Injury

  MAUDE report 19761835 ↗
• InjuryApr 8, 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 PAIN. THERE WAS NO DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 19058667 ↗
• InjuryMar 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATED EVENT DESCRIPTION: CLINICAL ADVERSE EVENT RECEIVED FOR TENDER POINT MID RIGHT SHIN AND PAINFUL RIGHT KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2020. DATE OF EVENT: UNK OCT 2023. (RIGHT KNEE). TREATMENT: INJECTED MEDICATION.

  Patient problems: Discomfort; Pain

  MAUDE report 18825499 ↗
• InjuryNov 15, 2023Adverse 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 NAUSEA AND VOMITING AND RE-ADMITTED TO HOSPITAL. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2005. DATE OF REVISION #1: (B)(6) 2022. DATE OF REVISION #2: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (RIGHT KNEE). TREATMENT: MEDICAL WORKUP RESULTING IN DX OF SHOWER EMBOLI AND TREATED WITH ELIQUIS.

  Patient problems: Embolism/Embolus; Nausea; Vomiting

  MAUDE report 18139720 ↗
• InjuryAug 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED RIGHT KNEE. REMOVAL OF IMPLANTS AND SPACER PLACEMENT WAS PERFORMED. DOI: UNKNOWN; DOR: (B)(6), 2023; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17611990 ↗
• InjuryMar 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAS INFECTION, ALL REVISION PROSTHESIS WERE EXTRACTED AND AN ANTIBIOTIC STATIC SPACER WAS IMPLANTED. THE SAME SURGEON, PERFORMED BOTH SURGERIES. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. UNKNOWN SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 16655138 ↗
• InjuryMar 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT HAS BEEN CREATED IN RELATION TO AEI NOTE: (B)(4) UNDER (B)(4) TO REPORT AND EVENT POST LEFT KNEE REVISION ON (B)(6) 2022, PATIENT HAS A LEFT DVT IN THE LEFT DFV THAT IS TREATED WITH ORAL BLOOD THINNERS. DOI: ON (B)(6) 2022, DOR: UNKNOWN, LEFT KNEE SECOND COMPLAINT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16627396 ↗
• InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A RIGHT TOTAL KNEE REPLACEMENT ON THE (B)(6) 2022 WHERE ATTUNE REVISION IMPLANTS WERE UTILISED. THE PATIENT PRESENTED FOR A REVISION PROCEDURE ON THE (B)(6) 2022 FOR AN UNKNOWN REASON.

  Patient problems: Insufficient Information

  MAUDE report 15579741 ↗
• MalfunctionAug 15, 2022Unintended Compatibility; Unintended Compatibility

  IT WAS REPORTED THAT THE TORQUE WRENCH FROM THE ASSEMBLY PAN HAD SLIPPED OUT OF THE GROOVE OF THE CEMENTED STEM WHILE LOCKING IT IN. IT WAS COLD WELDED AND COULDN¿T GET IT OFF. HAD TO OPEN ANOTHER ASSEMBLY PAN AND A NEW CEMENTED STEM. THE WRENCH AND THE STEM WERE BEING SENT BACK FOR ANALYSIS. THE DOCTOR SUGGESTED THAT THE WRENCH WAS EITHER WORN (WHICH HE DIDN¿T NOTICE ANY EVIDENCE OF IT), OR THE METAL WAS TOO SOFT TO BE ABLE TO CONTOUR THAT MUCH. A SURGICAL DELAY OF 3-5 MINUTES WAS NOTED.

  Patient problems: Insufficient Information

  MAUDE report 15223790 ↗
• InjuryJun 3, 2022Adverse 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 SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018. DATE OF EVENT (ONSET): (B)(6) 2022. (RIGHT KNEE). TREATMENT: KNEE REVISION ON (B)(6) 2022.

  Patient problems: Pain

  MAUDE report 14598015 ↗
• InjuryDec 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LOW GRADE INFECT EVENT IS SERIOUS AND IS CONSIDERED SEVERE EVENT IS PROBABLY RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018, DATE OF EVENT (ONSET): (B)(6) 2021, (RIGHT KNEE). TREATMENT: REVISION OF TIBIAL BASE PLATE, TIBIAL STEM, TIBIAL INSERT, AND FEMUR COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 13000463 ↗
• InjuryAug 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED KNEE. SURGEON EXPLANTED COMPONENTS REVISING WITH ARTICULATING SPACER. DOI: (B)(6) 2020 ; DOR: (B)(6) 2021 ; LEFT KNEE.

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

  MAUDE report 12385841 ↗
• MalfunctionAug 13, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT TKA FOR OA. THE SURGEON TRIED TO USE THE ATTUNE CRS FEMORAL COMPONENT AND THE CEMENTED STEM, BUT THE CEMENTED STEM COULD NOT BE ENGAGED WITH ATTUNE CRS FEMORAL COMPONENT. SINCE ANOTHER CEMENTED STEM HAD BEEN ARRANGED, THE SURGEON USED IT. IT HAD NO PROBLEM IN CONNECTING TO THE ATTUNE CRS FEMORAL COMPONENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY.

  Patient problems: Insufficient Information

  MAUDE report 12318657 ↗
• MalfunctionJul 23, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING IMPLANT ASSEMBLY, WHEN IT CAME TO SCREWING THE STEM DIRECTLY ON TO THE FEMORAL COMPONENT, IT DID NOT THREAD ON COMPLETELY. IT SAT ABOUT 5MM PROUD AND THEREFORE COULD NOT BE TORQUED ON. NO VISIBLE DAMAGE TO THE THREAD. NO SURGICAL DELAY OR PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12218123 ↗
• InjuryMar 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECORDS STATE THAT THE PATIENT UNDERWENT A R PRIMARY TOTAL KNEE ARTHROPLASTY IN 2019 USING UNKNOWN IMPLANTS. SHE THEN DEVELOPED A POSTOPERATIVE INFECTION REQUIRING A 1-STAGE EXCHANGE IN (B)(6) 2020 USING "TRUE COMPONENTS" OF UNKNOWN MANUFACTURER. THE CHRONIC INFECTION CONTINUED AND WAS CLEARED WITH ANTIBIOTICS. SHE UNDERWENT A FULL REVISION ON (B)(6) 2020 USING DEPUY COMPONENTS. PHYSICIAN CHECK-UP ON (B)(6) 2020 STATES SHE SUSTAINED A FALL AND CONTINUED TO HAVE PAIN, FLUID OVERLOAD AND REACTIVE CELLULITIS IN THE RIGHT LEG. ON (B)(6) 2021 AN MRI SHOWED NONDISPLACED FX OF THE RIGHT TIBIA ADJACENT TO THE STEM. PATIENT WAS TOLD TO USE A WALKING BOOT WITH WEIGHT RESTRICTIONS. A SEARCH OF THE CLINICAL DATABASE REVEALED NO INDICATION OF THE MANUFACTURER OF THE UNKNOWN IMPLANTS. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF EVENT (ONSET): (B)(6) 2021, (RIGHT KNEE).

  Patient problems: Fall; Pain

  MAUDE report 11544095 ↗
• InjuryJun 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ATTUNE REVISION FOR RECURRING INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10191779 ↗
• InjuryJan 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE OUTPATIENT SYNOVECTOMY. EVENT REQUIRED THE USE OF ORAL MEDICATION. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DOI: (B)(6) 2018. DOE: (B)(6) 2019, (LEFT KNEE).

  Patient problems: No Code Available; Pain

  MAUDE report 9646642 ↗
• InjuryJan 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE PAIN WHEN STANDING FROM SEATED POSITION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS REMOTELY POSSIBLY RELATED TO DEVICE AND PROBABLY RELATED TO PROCEDURE. DOI: UNKNOWN. DOR: (B)(6) 2018. DOE: (B)(6) 2019, (LEFT KNEE).

  Patient problems: No Code Available; Pain; Tissue Damage

  MAUDE report 9617644 ↗