ATTUNE 1506-40-003Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10603295042778), received between Oct 2, 2018 and Apr 15, 2026 — classified as 26 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (4 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 28 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED LOOSE TIBIAL IMPLANT. NO PATIENT COMPLICATIONS. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 24884595 ↗
• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. AND ALL COMPONENTS AND CEMENT WERE REMOVED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24586465 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO PAIN AND INSTABILITY IN THE RIGHT KNEE. BOTH THE LATERAL COLLATERAL LIGAMENT (LCL) AND MEDIAL COLLATERAL LIGAMENT (MCL) HAD BEEN SURGICALLY REPAIRED PREVIOUSLY. DOI: ON (B)(6) 2023, DOR: ON (B)(6) 2026, AFFECTED SIDE-RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 24532634 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED FOR INFECTION. SURGEON REMOVED PROSTHESIS PUT IN TEMPORARY SPACER. DOI: (B)(6) 2024, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24485175 ↗
• 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 PAIN.

  Patient problems: Pain

  MAUDE report 23924316 ↗
• InjuryDec 10, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT NEW REVISION DUE TO TIBIA CUT MADE IN VALGUS. PATIENT UNHAPPY WITH ALIGNMENT. DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23770313 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Fracture(s)

  MAUDE report 23526903 ↗
• InjuryOct 16, 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 EVENT RECEIVED FOR PERSISTENT PAIN IN LEFT KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2021, DATE OF EVENT: 01 DEC 2021, (LEFT KNEE). TREATMENT: ORAL MEDICATION AND DIAGNOSTIC INTERVENTION TREATMENT/IMPACT: INJECTED MEDICATION. DEPUY PRODUCTS USED (NO REVISION COMPLETED): DEVICE LOG FORM LOG LINE: 1 COMPONENT TYPE: FEMORAL COMPONENT CATALOG NUMBER: 150440103 LOT NUMBER ID: JC2497 DEVICE IDENTIFIER: (B)(4). DEVICE LOG FORM LOG LINE: 2 COMPONENT TYPE: TIBIAL BASE COMPONENT CATALOG NUMBER: 150640003 LOT NUMBER ID: 9773729 DEVICE IDENTIFIER: (B)(4). DEVICE LOG FORM LOG LINE: 3 COMPONENT TYPE: TIBIAL STEM CATALOG NUMBER: 151214030 LOT NUMBER ID: D21063066 DEVICE IDENTIFIER: (B)(4). DEVICE LOG FORM LOG LINE: 4 COMPONENT TYPE: TIBIAL INSERT COMPONENT CATALOG NUMBER: 151700312 LOT NUMBER ID: J03P07 DEVICE IDENTIFIER: (B)(4). DEVICE LOG FORM LOG LINE: 5 COMPONENT TYPE: CEMENT CATALOG NUMBER: 66017750 LOT NUMBER ID: 97671012 DEVICE IDENTIFIER: (B)(4). DEVICE LOG FORM LOG LINE: 6 COMPONENT TYPE: CEMENT CATALOG NUMBER: 66017750 LOT NUMBER ID: 97714988

  Patient problems: Pain

  MAUDE report 23309970 ↗
• InjuryJan 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION IN THE KNEE THAT REQUIRED AN EXPLANT, AND ANTIBIOTIC SPACER WAS IMPLANTED. NO FURTHER INFORMATION WAS AVAILABLE. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21092204 ↗
• InjuryApr 29, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF TIBIAL COMPONENT AT THE UNKNOWN INTERFACE. DOI: UNK. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19201918 ↗
• InjuryJul 31, 2023No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT BEFORE THE SURGERY, THE PRODUCTS IN QUESTION ORDERED FOR THE SURGERY VIA TKA FOR THE LEFT OA COULD NOT BE FOUND. THE PATIENT WAS ALREADY UNDER GENERAL ANESTHESIA, BUT THE SURGERY WAS CANCELLED AT THE SURGEON'S DISCRETION. THE SURGEON COMMENTED THAT HE WOULD LIKE A REPORT ON THE WHEREABOUTS OF THE MISSING IMPLANTS AND HOW THIS HAPPENED. IT WAS LATER DISCOVERED THAT THIS OCCURRED BECAUSE THE AGENCY HAD MISTAKENLY RETURNED THE PRODUCTS THAT SHOULD NOT HAVE BEEN RETURNED DUE TO A LACK OF CONFIRMATION BY THE AGENCY.

  Patient problems: Insufficient Information

  MAUDE report 17423733 ↗
• InjuryMay 15, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL TRAY AT THE UNKNOWN INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. PATIENT WAS REVISED WITH REMOVAL OF LOOSE TIBIA AND POLY. REPLACED WITH A LONGER STEMMED TIBIA AND NEW POLY NOTHING MORE TO REPORT. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 16933608 ↗
• InjuryJul 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, REMOVAL OF THE TOTAL JOINT PROSTHESIS AND AN INSERTION OF AN ANTIBIOTIC SPACER DUE TO INFECTION WAS DONE. THERE WAS A LOOSENING OF THE FEMUR AND TIBIA IN THE BONE TO CEMENT INTERPHASE. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15098171 ↗
• InjuryMay 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MOBILIZATION OF THE KNEE PROSTHESIS. REVISION OF THE LEFT KNEE PROSTHESIS AS PAINFUL AND RIGID.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 14419189 ↗
• InjuryApr 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PAIN, STIFFNESS AND INFECTION. EVENT IS NOT SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2021; DATE OF IMPLANT (INSERT): (B)(6) 2021; DATE OF EVENT: (B)(6) 2021; (RIGHT KNEE). TREATMENT: IV AND ORAL ANTIBIOTICS, PHYSICAL THERAPY.

  Patient problems: Muscular Rigidity; Pain; Unspecified Infection

  MAUDE report 14169473 ↗
• 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 13653042 ↗
• 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 12711979 ↗
• 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 12234466 ↗
• InjuryJun 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PERSISTING PAIN. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS PROBABLY RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT (ONSET): (B)(6) 2020. (LEFT KNEE). TREATMENT: INJECTED AND ORAL MEDICATIONS (UNSPECIFIED), PHYSICAL THERAPY.

  Patient problems: Pain

  MAUDE report 11933346 ↗
• InjuryFeb 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A SYSTEMIC INFECTION WHICH SETTLED IN HER KNEE AND SHOULDER. FRANK PUS WAS ENCOUNTERED. THE KNEE WAS WASHED OUT AND A NEW INSERT WAS PLACED ON 11-14-20. SHE RETURNED TO THE OR TODAY AND ALL THE IMPLANTS WERE REMOVED. A TC3 FEMUR AND A TC3 RP INSERT WERE PLACED AS SPACERS. NO SURGICAL DELAY. DOI: (B)(6) 2020 (TRAY, FEMORAL, INSERT, PATELLA). DOR: (B)(6) 2020 (INSERT). DOR: (B)(6) 2021 (ALL IMPLANTS); LEFT KNEE.

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

  MAUDE report 11292689 ↗
• InjuryApr 13, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  CLINICAL ADVERSE EVENT RECEIVED FOR WOUND HEMATOMA. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE AND DEFINITELY RELATED TO PROCEDURE. TREATMENT INCLUDES IRRIGATION AND DEBRIDEMENT. PATIENT REPORTED DISSATISFACTION IN A CLINICAL SURVEY. (RIGHT KNEE).

  Patient problems: Hematoma; No Code Available; Pain

  MAUDE report 9954623 ↗
• InjuryJan 8, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2018, THE PATIENT UNDERWENT A 2ND RIGHT KNEE REVISION DUE TO INFECTION AND TIBIAL LOOSENING. THE SURGEON REPORTED THE TIBIAL COMPONENT WAS LOOSE. HE INDICATED THE TIBIA WAS SIGNIFICANTLY INFECTED WITH OSTEOMYELITIS WHICH WAS RESECTED. HE REPORTED THE REMOVAL OF THE FEMORAL AND PATELLAR COMPONENTS. COMPETITOR SYSTEM AND CEMENTS WERE IMPLANTED IN THE REVISION. THERE WERE NO COMPLICATIONS REPORTED. AWARENESS DATE IS (B)(6) 2019. DOI: (B)(6) 2015 (FEMUR, PATELLA); DOI: (B)(6) 2017(ONE DEPUY CEMENT, STEM, TRAY, INSERT); DOR: (B)(6) 2018 (RT KNEE).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9563943 ↗
• InjuryJul 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN. NO ACUTE INFLAMMATION ON TEST RESULTS FROM LAB. DOI: (B)(6) 2017; DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8784661 ↗
• MalfunctionApr 2, 2019Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE AUGMENT SCREWS WOULD NOT GO IN STRAIGHT AND GOT STUCK. HAD TO OPEN NEW IMPLANTS. ONE OF THEM ALSO GOT STUCK. THEY WERE ABLE TO IMPLANT THE SECOND SET OF IMPLANTS BUT NO CONFIDENCE THAT AUGMENT WAS PROPERLY LOCKED. ARTICULATING SCREWDRIVER IN ATTUNE REVISION SET DOES NOT WORK EFFECTIVELY. NEED A DIFFERENT OPTION. DOE: (B)(6) 2019. RIGHT KNEE.

  Patient problems: Not Applicable

  MAUDE report 8473155 ↗
• InjuryMar 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: (B)(6) 2018 (TIBIAL BASE, STEM AND FEMORAL); DOI: (B)(6) 2018 (INSERT); DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8399284 ↗

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-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-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-2348-2021 · Jul 1, 2021 · Terminated
  ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080
• Z-1704-2018 · Apr 16, 2018 · Terminated
  ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral Revision Implant, Knee
• Z-1703-2018 · Apr 16, 2018 · Terminated
  ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee