ATTUNE 1506-40-004Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10603295042785), received between Jan 15, 2019 and Jan 23, 2026 — classified as 38 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (5 reports).

5 other recalls cover devices cleared under the same FDA submission (K160700, K241000); they may or may not involve this specific model.

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 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6), STUDY NO:(B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR NO INFORMATION PROVIDED DCLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE OEDEMA DEVICE RELATED: REMOTE POSSIBILITY PROCEDURE RELATED: DEFINITELY. TREATMENT/IMPACT: OTHER (DRAINAGE) DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 150440106 LOT NUMBER: J0841J COMPONENT TYPE: FEMORAL COMPONENT DESCRIPTION: ATTUNE REVISION CRS FEMORAL SIZE 6 LEFT CEMENTED. CATALOG NUMBER: 150640004 LOT NUMBER: 9640684 COMPONENT TYPE: TIBIAL BASE COMPONENT DESCRIPTION: ATTUNE REVISION TIBIAL BASE FIXED BEARING SIZE 4 CEMENTED. CATALOG NUMBER: 151700608 LOT NUMBER: H80128 COMPONENT TYPE: TIBIAL INSERT COMPONENT DESCRIPTION: ATTUNE REVISION CRS FIXED BEARING INSERT SIZE 6 8 MM. CATALOG NUMBER: 66017750 LOT NUMBER: 95654956 COMPONENT TYPE: CEMENT DESCRIPTION: HERAEUS MEDICAL GMBH PALACOS CEMENT. CATALOG NUMBER: 66017750 LOT NUMBER: 95904875 COMPONENT TYPE: CEMENT DESCRIPTION: HERAEUS MEDICAL GMBH PALACOS CEMENT.

  Patient problems: Swelling/ Edema

  MAUDE report 24159596 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK FOR Q4 OF 2025. DARTMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION FOR A PERIPROSTHETIC FRACTURE POST FALL. LOCATION OF FRACTURE IS NOT IDENTIFIED. THE ARTICULAR SURFACE OF THE REVISED INSERT SHOWS SEVERE PITTING AND MODERATE ABRASION

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 23922607 ↗
• InjuryJul 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTS IN OFFICE POST FALL ROUGHLY 6 WEEKS PRIOR POST TOTAL KNEE. SHE NOW COMPLAINS OF PAIN AND INSTABILITY. PHYSICAL EXAM LED SURGEON TO BELIEVE SHE HAD RUPTURED HER MCL AT THE TIME OF FALL AND SHE IS SCHEDULED FOR A REVISION TO ADDRESS. PATIENT HAD BEEN DOING WELL PRIOR TO THE STATED FALL AND WAS VERY HAPPY WITH HER KNEE PRIOR TO THE FALL. PATIENT IS MORBIDLY OBESE AND IS CONSIDERED A CONTRIBUTING FACTOR. DURING SURGERY, THE MCL WAS CONFIRMED TO BE DEFICIENT, ESPECIALLY AT HER SIZE, AND WELL FIXED AND WELL ALIGNED COMPONENTS WERE REMOVED AND A HINGED KNEE CONSTRUCT WAS PLACED WITH NO DELAY NOR PATIENT HARM. NO ALLEGATIONS WERE MADE AGAINST ANY COMPONENT. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Joint Laxity; Pain

  MAUDE report 22565799 ↗
• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTED PRIMARY KNEE. COMPONENTS WERE REMOVED AND NEW IMPLANTS USED AS TEMPORARY SPACER. THERE WERE NO COMPLAINTS OR DELAYS. COMPONENTS UNAVAILABLE FOR RETURN. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22338512 ↗
• InjuryNov 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LCL WAS TORN AND NOT REPAIRABLE. SURGEON REMOVED COMPONENTS AND CONVERTED TO SROM. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20678918 ↗
• InjuryJul 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATED EVENT DESCRIPTION: DATE OF REVISION: (B)(6) 2025. TREATMENT/IMPACT: REVISION OF STUDY JOINT, HOSPITALIZATION AND ATTUNE TIBIAL INSERT.

  Patient problems: Pain

  MAUDE report 19701952 ↗
• InjuryMay 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR WORSENING OF RIGHT SHIN PAIN LEADING TO POLY EXCHANGE AND PATELLAR RESURFACING. TREATMENT/IMPACT: HOSPITALIZATION, INJECTED MEDICATION, REVISION OF STUDY JOINT.

  Patient problems: Pain

  MAUDE report 19346011 ↗
• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD DEVELOPED A FLEXION CONTRACTURE AND COULD NO LONGER ACHIEVE FULL EXTENSION. OPERATIVELY, IT WAS NOTED THAT THE PATIENT HAD A FLEXION EXTENSION MISMATCH. COMPONENTS WERE REMOVED AND A REVISION HINGED KNEE WAS PLACED UNEVENTFULLY. ALL COMPONENTS WERE APPROPRIATELY SIZED, WELL ALIGNED, WELL FIXED WITH AN APPROPRIATE JOINT LINE. NO DELAY OCCURRED AND NO PATIENT HARM WAS NOTED. CEMENT WAS HOSPITAL OWNED SO NO RECORDS ARE AVAILABLE. PATELLAR IMPLANT WAS RETAINED FROM INITIAL SURGERY AS IT WAS WELL FIXED AND TRACKED APPROPRIATELY. PATIENT DID HAVE AN ADDITIONAL SURGERY ON (B)(6) 2022 AND WAS CAPTURED IN (B)(4). THE INSERT WAS EXCHANGED AT THAT TIME, HOWEVER DUE TO A CHANGE FROM COMPASS TO OPTIMIZE IN OUR TERRITORY, FEW RECORDS OTHER THAN INSERT SIZE ARE CURRENTLY AVAILABLE. PLEASE NOTE THAT THE SAME SIZE INSERT WAS UTILIZED. NO LOT NUMBERS ARE AVAILABLE FOR THE SAME REASON. DOI: (B)(6) 2023 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Contracture; Loss of Range of Motion

  MAUDE report 18493175 ↗
• InjuryAug 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: -THE INSTABILITY WAS DUE TO THE PATIENTS SIZE/BMI AND LIGAMENT LAXITY. THERE WAS NO ISSUE WITH THE IMPLANT, NO WEAR OR LOOSENING.

  Patient problems: Joint Laxity

  MAUDE report 17584038 ↗
• InjuryJun 12, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED FOR ANTERIOR KNEE PAIN. THERE WAS LOOSENING OF TIBIA COMPONENT AT AN UNKNOWN INTERFACE REPORTED UPON EXPLORATION. TIBIA, POLY AND PATELLA EXCHANGE WAS PERFORMED. ATTUNE FB KNEE ORIGINALLY IMPLANTED IN 2014. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 17105866 ↗
• InjuryMar 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ACUTE BLOOD LOSS ANEMIA. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2018. DATE OF EVENT: (B)(6) 2018. (LEFT KNEE). TREATMENT: INJECTED MEDICATION.

  Patient problems: Anemia; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16609058 ↗
• InjuryFeb 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR STIFFNESS IN JOINT. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2017. DATE OF EVENT: UNK (B)(6) 2018. (RIGHT KNEE). TREATMENT: INJECTED MEDICATION, ORAL MEDICATION, AND PHYSICAL THERAPY.

  Patient problems: Muscular Rigidity

  MAUDE report 16452010 ↗
• InjuryJan 9, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT THE SURGERY VIA TKA FOR RIGHT TRAUMATIC KNEE OSTEOARTHRITIS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, IT WAS CONFIRMED THAT LOOSENING AND DE-BONDING OF THE TIBIAL TRAY-CEMENT INTERFACE. THE REVISION SURGERY WAS DONE ON (B)(6) 2022. THE SURGEON COMMENTED THAT THE MISMATCH DUE TO THE UNDERSIZED PLACEMENT OF THE TIBIAL TRAY ALSO HAD AN EFFECT. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 16122649 ↗
• InjuryDec 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ABSCESS LEFT THIGH. 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) 2022. (LEFT KNEE). TREATMENT: SURGERY NOT RELATED TO STUDY KNEE.

  Patient problems: Abscess

  MAUDE report 16072870 ↗
• InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PAIN DUE TO TOTAL KNEE REPLACEMENT. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2018, DATE OF EVENT: (B)(6) 2021, (RIGHT KNEE). TREATMENT: INJECTED MEDICATION AND ORAL MEDICATION.

  Patient problems: Pain

  MAUDE report 15580144 ↗
• InjuryOct 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO KNEE PAIN. THERE WAS NO LOOSENING. SURGICAL DELAY WAS REPORTED UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 15562296 ↗
• InjuryJul 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR KNEE ARTHROFIBROSIS. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: DATE OF EVENT: (B)(6) 2018, RIGHT KNEE. TREATMENT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Adhesion(s)

  MAUDE report 14886670 ↗
• InjuryApr 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR POST-OPERATIVE SWELLING. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS NOT RELATED TO DEVICE AND IS RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2021, DATE OF EVENT: (B)(6) 2021, (RIGHT KNEE). TREATMENT: ASPIRATION AND DRAINAGE, KNEE BRACE.

  Patient problems: Swelling/ Edema

  MAUDE report 14194074 ↗
• InjuryDec 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RETURNED TO SURGERY FOR AN INFECTION. ALL IMPLANTS WERE REMOVED AND A SPACER WAS PLACED. DOI: (B)(6) 2021. DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13044137 ↗
• InjuryDec 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2021, LEFT KNEE. DOI : UNKNOWN DOR : (B)(6) 2021 LEFT SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 12954141 ↗
• InjuryDec 2, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  CLINICAL ADVERSE EVENT RECEIVED FOR TIBIAL DISLOCATION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS PROBABLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF EVENT (ONSET): (B)(6) 20201, (RIGHT KNEE). TREATMENT: KNEE REVISION (B)(6) 2021. THE CLINICAL DATABASE NOW REPORTS THAT THERE HAS BEEN A KNEE REVISION--RIGHT KNEE WAS REVISED FOR LOOSENING TIBIAL COMPONENT, RIGHT KNEE--THAT OCCURRED ON (B)(6) 2021. TIBIAL TRAY, TIBIAL INSERT, TIBIAL STEM, OFFSET ADAPTOR, AND TIBIAL AUGMENT WERE REPORTEDLY REVISED--FEMUR AND PATELLA COMPONENTS WERE RETAINED.

  Patient problems: Insufficient Information

  MAUDE report 12915586 ↗
• InjuryOct 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO SURGEON'S CLINIC FOR FOLLOW UP FROM HER PREVIOUSLY REVISED TIBIAL COMPONENT WITH ANTERIOR KNEE/TIBIAL PAIN. AFTER EXAMINATION, SURGEON RECOMMENDED SHORTENING THE TIBIAL STEM COMPONENT BECAUSE HE THOUGHT THE CURRENT IMPLANT WAS CAUSING HER PAIN. AFTER SEVERAL WEEKS OF CONSIDERATION, SHE DECIDED TO PROCEED WITH THE SURGEON'S RECOMMENDATION TO SHORTEN THE TIBIAL CONSTRUCT. SHE WAS THEN BROUGHT TO THE OPERATING ROOM WHERE A STAT GRAM STAIN WAS PERFORMED TO RULE OUT INFECTION. THE TIBIAL CONSTRUCT WAS REMOVED USING THE SURGEON'S TOOLS OF CHOICE, PRESERVING THE NATIVE TIBIA. AN RP COMPONENT WITH A FULLY POROUS PROXIMAL SLEEVE WITH 5MM AUGMENTS WAS IMPLANTED ACCORDING TO THE SURGEON'S PREFERENCE. DOI: UNKNOWN. DOR: (B)(6) 2021. UNKNOWN LEFT SIDE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 12661563 ↗
• InjuryAug 10, 2021Migration; Migration

  PATIENT WAS REVISED DUE TO TIBIA HAD COLLAPSED ON THE LATERAL SIDE AND THE PATIENT ACCORDING TO THE REVISION SURGEON SAID THAT THE PATIENT MUST HAVE FALLEN. SURGEON BELIEVED THE MCL WAS COMPROMISED. SURGEON REMOVED ALL COMPONENTS AND FELT THAT PUTTING A HINGE TKA WAS BEST FOR THE PATIENT MOVING FORWARD. PATIENT HAD A PRIMARY LT TKA DONE 7-1-2019, PATIENT THAT TIME HAD "SOFT BONE" ACCORDING TO THE PRIMARY SURGEON. THE SURGEON FELT THAT PUTTING IN A STEM ON TIBIA TRAY WAS BEST FOR PATIENT AND 2 YEARS LATER THE PATIENT NEEDS A REVISION. PATELLA WAS NOT REMOVED. DOI: (B)(6) 2019 ; DOR: (B)(6) 2021 ; LEFT KNEE.

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

  MAUDE report 12301416 ↗
• InjuryJul 21, 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 FRACTURE ON LEFT KNEE TKA. EVENT IS NOT SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF EVENT (ONSET): (B)(6) 2021, (LEFT KNEE). TREATMENT: OPEN REDUCTION INTERNAL FIXATION WITH NO REVISION OF PRODUCTS.

  Patient problems: Bone Fracture(s)

  MAUDE report 12206945 ↗
• InjuryJun 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR DEEP VENOUS THROMBOSIS. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020. DATE OF EVENT (ONSET): (B)(6) 2020. (LEFT KNEE) TREATMENT: ORAL MEDICATION (UNSPECIFIED).

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11971211 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160700, K241000. One submission often covers many models, so check the product and lot details in each record.

• Z-0632-2022 · Jan 5, 2022 · Terminated
  ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154706001
• Z-0631-2022 · Jan 5, 2022 · Terminated
  ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154909003
• Z-2348-2021 · Jul 1, 2021 · Terminated
  ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080
• Z-1703-2018 · Apr 16, 2018 · Terminated
  ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee
• Z-1704-2018 · Apr 16, 2018 · Terminated
  ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral Revision Implant, Knee