ATTUNE 1506-40-006Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10603295042808), received between Jan 10, 2018 and Mar 6, 2026 — classified as 22 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (1 report).

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 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.

• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTION. ANTIBIOTIC SPACER WAS PLACED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24530605 ↗
• MalfunctionDec 17, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) WITH A CRUCIATE-RETAINING FEMORAL MULTI-SIZE POLYETHYLENE, THE SURGEON IMPACTED THE POLYETHYLENE INSERT AND FELT THE LOCKING MECHANISM DID NOT ENGAGE CORRECTLY. THE SURGEON REMOVED AND REINSERTED THE INSERT SEVERAL TIMES AND OPENED A SECOND AND THEN A THIRD POLYETHYLENE WITH THE SAME ISSUE. AFTER A FOURTH POLYETHYLENE WAS OPENED AND STILL DID NOT SATISFY THE SURGEON, A STEMMED TIBIAL COMPONENT WAS OPENED IN CASE TRAY REMOVAL WAS REQUIRED AND TO EVALUATE WHETHER THE TIBIAL TRAY MIGHT BE CAUSING THE LOCKING FAILURE; THE TEAM ATTEMPTED TO ENGAGE THE POLYETHYLENE AND TRAY ON THE BACK TABLE. THE SURGEON WAS NOT CONVINCED THAT CHANGING TRAYS WOULD RESOLVE THE PROBLEM AND ULTIMATELY IMPLANTED A 6X7 LEFT MULTI-SIZE POLYETHYLENE, ALTHOUGH THE SURGEON REMAINED NOT FULLY SATISFIED AT THE CONCLUSION OF THE CASE. NO FURTHER INFORMATION IS AVAILABLE. DOE: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23830245 ↗
• InjuryOct 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENTS RECEIVED FOR DEEP VEIN THROMBOSIS OF LEFT LOWER EXTREMITY DEVICE AND PROCEDURE(RELATEDNESS). DEVICE RELATED: POSSIBLY. PROCEDURE RELATED: POSSIBLY. DATE OF EVENT: (B)(6) 2019. DATE OF IMPLANT: (B)(6) 2018. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: ORAL MEDICATION.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20443790 ↗
• 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 19376263 ↗
• InjuryApr 24, 2024Naturally Worn; Naturally Worn

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: POLY WEAR AND METAL WEAR. POSTERIOR INSERT WAS NOTED TO BE BROKEN.

  Patient problems: Insufficient Information

  MAUDE report 19174856 ↗
• InjuryAug 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INCREASED SWELLING OF LEFT KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

  Patient problems: Swelling/ Edema

  MAUDE report 17488314 ↗
• InjuryNov 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH REMOVAL OF TOTAL KNEE CONSTRUCT AND PLACEMENT OF ARTICULATING ANTIBIOTIC SPACER DUE TO PRESENCE OF INFECTION. DOI: (B)(6) 2020 DOR: (B)(6) 2022 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15714335 ↗
• 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 15163126 ↗
• InjuryJun 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY:(B)(4) 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. (RIGHT KNEE). TREATMENT: AWAITING MANIPULATION UNDER ANESTHESIA.

  Patient problems: Loss of Range of Motion

  MAUDE report 14655644 ↗
• InjuryFeb 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LOWER RESPIRATORY TRACT INFECTION. 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): (B)(6) 2022. (UNKNOWN KNEE). TREATMENT: UNSPECIFIED INJECTED AND ORAL MEDICATION.

  Patient problems: Unspecified Infection

  MAUDE report 13422731 ↗
• InjuryFeb 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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): (B)(6) 2022 (UNKNOWN KNEE). TREATMENT: UNSPECIFIED INJECTED MEDICATION, UNSPECIFIED ORAL MEDICATION, AND FEMORAL NERVE BLOCK.

  Patient problems: Pain

  MAUDE report 13415708 ↗
• 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 13000386 ↗
• MalfunctionOct 5, 2021Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE AFFECTED SIDE WAS THE LEFT SIDE AND THERE WAS NO ADVERSE EFFECTS TO PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 12576377 ↗
• 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 12385839 ↗
• InjuryAug 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS STATED THAT 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 12384543 ↗
• InjuryJul 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR RIGHT KNEE MANIPULATION UNDER ANESTHESIA & STEROID INJECTION DUE TO STIFFNESS CAUSING FLEXION DEFORMITY. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. THERE IS A REMOTE POSSIBILITY THE EVENT IS RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT (ONSET): (B)(6) 2021. (RIGHT KNEE). TREATMENT: MANIPULATION UNDER ANESTHESIA & STEROID INJECTION.

  Patient problems: Joint Contracture; Loss of Range of Motion; Muscular Rigidity

  MAUDE report 12189223 ↗
• InjuryNov 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR SEPTIC KNEE: INFECTION - DEEP. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF EVENT (ONSET): (B)(6) 2020. (RIGHT KNEE). TREATMENT: AWAITING REVISION SURGERY.

  Patient problems: Edema; Injury; No Code Available; Pain; Unspecified Infection

  MAUDE report 10872336 ↗
• InjurySep 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ATRIAL FIBRILLATION, FAST FLUTTER AND FAST REPOSED CHEST INFECTION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE EVENT IS DEFINITELY NOT RELATED TO DEVICE AND DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT (ONSET): (B)(6) 2020. (RIGHT KNEE). TREATMENT: ORAL MEDICATION.

  Patient problems: Atrial Tachycardia; No Code Available; Unspecified Infection

  MAUDE report 10574226 ↗
• InjuryJan 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). (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 9646640 ↗
• 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 9617649 ↗
• InjuryJan 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR RERUPTURE PATELLAR TENDON, SEPTIC ARTHRITIS LEFT 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) 2018, DATE OF EVENT (ONSET): (B)(6) 2018, (LEFT KNEE). TREATMENT: LEFT KNEE REVISED, WITH REMOVAL OF FEMUR, TIBIAL TRAY, TIBIAL INSERT, OFFSET ADAPTOR, AND TIBIAL STEM. PRODUCT DETAILS: COMPONENT TYPE: SMART SET MV BONE CEMENT 40G, CATALOG NUMBER: 3122040, LOT NUMBER: 8661745. COMPONENT TYPE: SMART SET MV BONE CEMENT 40G, CATALOG NUMBER: 3122040, LOT NUMBER: 8661745. COMPONENT TYPE: ATTUNE REVISION OFFSET STEM ADAPTOR 4 MM, CATALOG NUMBER: 151304000, LOT NUMBER: 8656523. COMPONENT TYPE: ATTUNE REVISION PRESSFIT STEM 16 MM X 60 MM, CATALOG NUMBER: 151316060, LOT NUMBER: HR5221. COMPONENT TYPE: ATTUNE P/S FEM LT SZ 7 CEM, CATALOG NUMBER: 150410107, LOT NUMBER: 8309667. COMPONENT TYPE: ATTUNE REVISION TIBIAL BASE FIXED BEARING SIZE 6 CEMENTED, CATALOG NUMBER: 150640006, LOT NUMBER: 8505990. COMPONENT TYPE: ATTUNE PS FB INSRT SZ 7 14MM, CATALOG NUMBER: 151640714, LOT NUMBER: 502626.

  Patient problems: Unspecified Infection

  MAUDE report 9565593 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017: THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY. ATTUNE IMPLANTS WERE UTILIZED WITH DEPUY CEMENT X2. PATELLA WAS RESURFACED. NO INTRAOPERATIVE COMPLICATIONS WERE NOTED. ON (B)(6) 2018: THE PATIENT UNDERWENT A REVISION OF THE RIGHT KNEE FOR PAIN, MILD EFFUSION, AND RADIOGRAPHIC DETECTION OF INCREASED BONE UPTAKE IN FEMUR AND TIBIA. INTRAOPERATIVELY, THE TIBIA TRAY WAS FOUND INTERNALLY ROTATED AND SURGEON NOTES IMPLIES TIBIAL TRAY LOOSE AT IMPLANT-CEMENT INTERFACE AS THE COMPONENT DISENGAGED FROM CEMENT MANTLE WITH ONE ATTEMPT WHILE LEAVING CEMENT MANTLE ADHERED TO TIBIA. NO INFECTION. PATELLA WAS NOT REVISED. ONLY THE TIBIA TRAY AND POLY INSERT WERE REPLACED. THIS IS CAPTURED ON (B)(4). ON (B)(6) 2018: PATIENT DIAGNOSED WITH RIGHT KNEE WOUND DEHISCENCE WITH SUPERFICIAL INFECTION. PATIENT RECEIVED IRRIGATION AND DEBRIDEMENT DUE TO INFECTION. INTRAOPERATIVELY, SURGEON FOUND ARTHROTOMY COMPLETELY INTACT AND NOT ABLE TO EXPRESS FLUID FROM ARTHROTOMY ITSELF. NO IMPLANTS REMOVED AT THIS PROCEDURE. ON (B)(6) 2018: PATIENT DIAGNOSED WITH INFECTED RIGHT KNEE ARTHROPLASTY AND RECEIVES RESECTION OF RIGHT KNEE ARTHROPLASTY WITH PLACEMENT OF DYNAMIC SPACER. PATIENT RECEIVED

  Patient problems: No Code Available; Unspecified Infection; Wound Dehiscence

  MAUDE report 9545560 ↗
• InjuryOct 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED 17 JUNE 2019 AND WERE REVIEWED 30 SEPTEMBER 2019 FOR MDR REPORTABILITY. ON (B)(6) 2018, THE PATIENT UNDERWENT TOTAL RIGHT KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS. THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH THE ATTUNE KNEE SYSTEM AND SMARTSET BONE CEMENT X 2. ON (B)(6) 2018, THE PATIENT UNDERWENT STAGE 1 REVISION WITH ANTIBIOTIC SPACER, TO THE RIGHT KNEE DUE TO INFECTION. THE PATIENT WAS IMPLANTED WITH A CEMENT AND THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2018; DOR: (B)(6) 2018; (RT KNEE).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9209767 ↗
• InjuryJan 10, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  DER STATES TIBIAL COMPONENT REVISION DUE TO TIBIAL LOOSENING. ATTUNE RP TIBIA WAS REMOVED. THE LOOSENING WAS ASEPTIC.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7178065 ↗

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