ATTUNE 1506-40-007Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295042815), received between Jan 25, 2018 and May 8, 2024 — classified as 15 injuries, 2 malfunctions.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryMay 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STAGE 1 REVISION BEING PERFORMED DUE TO INFECTION. ALL IMPLANTS WERE REMOVED SUCCESSFULLY. NO DELAY. NO OTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2020 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19268437 ↗
• InjuryMay 2, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PAIN AND IMPLANT DISLOCATION. IT WAS REPORTED THAT A REVISION IS NEEDED. DOI: (B)(6) 2023. DOE: 27 MAR 2024. ADDITIONAL INFORMATION RECEIVED: A. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO DELAY. B. CAN YOU PLEASE SPECIFY WHICH IMPLANT WAS DISLOCATED? NO IMPLANT DISLOCATION. C. DID THE TIBIAL INSERT DISLOCATE FROM THE TIBIAL TRAY OR DID THE INSERT DISLOCATE FROM THE FEMORAL COMPONENT. THE INSERT WAS IN PLACE. D. DID THE TIBIAL INSERT COME ALL THE WAY OUT OF THE TRAY (DISLOCATION) OR DID IT PARTIALLY COME OUT OF THE TRAY? -SPIN-OUT) THE INSERT HAS BEEN FORCIBLY REMOVED FROM THE TIBIAL IMPLANT. NO DISLOCATION.

  Patient problems: Pain

  MAUDE report 19230521 ↗
• InjuryDec 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED KNEE AND LOOSENING OF FEMUR AT BONE TO CEMENT INTERFACE. SURGICAL DELAY UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18357988 ↗
• MalfunctionMay 11, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING TOTAL KNEE ARTHROPLASTY, WHEN THE SURGEON OPENED THE TIBIAL PACKAGE A LONG HAIR WAS FOUND INSIDE, WRAPPED AROUND THE IMPLANT. THE IMPLANT WAS PASSED OFF THE FIELD AND NOT USED. A NEW IMPLANT WAS OPENED. THERE WERE NO BROKEN DEPUY PRODUCTS, AND THERE WAS 5 MIN DELAY TO GET ANOTHER IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16913560 ↗
• InjuryAug 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2021; DOR: (B)(6) 2022; LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15156210 ↗
• InjuryMay 5, 2022Migration; Migration

  IT WAS REPORTED THAT THERE WAS A SUBSIDENCE OF THE TIBIAL COMPONENT. THE SURGEON EXPLANTED THE TIBIA REVISING IT WITH RP REV TRAY & LONGER STEM. NO SURGICAL DELAY. DOI: (B)(6) 2019; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 14287724 ↗
• MalfunctionDec 9, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE INSERT WOULD NOT ENGAGE AND SEAT IN THE TIBIA TRAY. SURGICAL DELAY 3 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 12967735 ↗
• InjuryNov 17, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO PAINFUL LEFT KNEE AND LOOSENING OF THE TIBIA COMPONENT AT THE BONE TO CEMENT & CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. DOI: (B)(6) 2019. DOR: (B)(6) 2021. LEFT KNEE.

  Patient problems: Pain

  MAUDE report 12833150 ↗
• InjuryOct 18, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  SUBJECT ID: (B)(6). STUDY: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR TIBIAL LOOSENING. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF EVENT (ONSET): (B)(6) 2021, (RIGHT KNEE) . TREATMENT: REVISION OF INSERT, AND BOTH TIBIAL AND FEMORAL REVISION CONSTRUCTS.

  Patient problems: Insufficient Information

  MAUDE report 12646808 ↗
• InjuryJul 15, 2021Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. A DEPUY CEMENT WAS USED. IT WAS REPORTED THAT IT WAS NOTICED BASED ON X-RAY THAT THE TIBIAL COMPONENT COLLAPSED AND BECAME LOOSE. NO DELAY IN SURGERY. DOI: (B)(6) 2019. DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Pain

  MAUDE report 12174293 ↗
• InjuryMar 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED TO ADDRESS INFECTION. NO LOOSENING AND NO DELAY IN SURGERY. DOI: (B)(6) 2020. DOR: (B)(6) 2021; RIGHT KNEE.

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

  MAUDE report 11568398 ↗
• InjuryApr 6, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT RECEIVED A TOTAL LEFT TKA REVISION TO TREAT PERSISTENT PAIN. THE TIBIAL TRAY WAS LOOSE AND COMPLETELY DEBONDED AT THE CEMENT TO IMPLANT INTERFACE. THE SURGEON NOTES THAT THE SOFT TISSUE SURROUNDING THE TIBIAL CEMENT MANTLE WAS NECROTIC AND NEEDED EXTENSIVE DEBRIDEMENT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2015. DOR: (B)(6) 2018 (TRAY AND INSERT (B)(4)). DOR: (B)(6) 2020 (TOTAL REVISION). LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9929311 ↗
• InjuryFeb 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INFECTION TKP. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. REMOTE POSSIBILITY THAT THE EVENT IS RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT (ONSET): (B)(6) 2019, (LEFT KNEE). TREATMENT: SURGICAL IRRIGATION & DEBRIDEMENT, (NO REVISION OF INSERT), IV AND ORAL ANTIBIOTICS.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9748767 ↗
• InjuryNov 4, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LAXITY AND LOOSENING OF THE TIBIAL TRAY AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. IT WAS ALSO REPORTED THAT THE LAXITY IS PRESENT IN BOTH FLEXION AND EXTENSION. THE SURGEON PLANNED TO PUT IN A THICKER INSERT. THE SURGEON DECIDED ALSO TO REVISED THE FEMUR. THE PATELLA WAS RETAINED AND WAS WELL FIXED. THE FEMUR WAS WELL FIXED, BUT THE PATIENT NEEDED BETTER EXTENSION, SO REVISING THE FEMUR AND MOVING IT PROXIMAL WAS THE BEST PLAN. NO CEMENT STUCK TO THE UNDERSIDE OF THE TIBIAL TRAY. DOI: (B)(6) 2018. DOR: (B)(6) 2019. LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9274756 ↗
• InjuryApr 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS QUADRACEPS RUPTURE DUE TO FALL, UROSEPSIS AND INFECTION. DOI: (B)(6) 2018; DOR: (B)(6) 2018, LEFT KNEE.

  Patient problems: Not Applicable; Tissue Damage; Unspecified Infection

  MAUDE report 7425255 ↗
• InjuryFeb 21, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. IT WAS ALSO INDICATED THAT THE SURGEON REMOVED ALL IMPLANTS AND REPLACED WITH ANTIBIOTIC SPACER. DOI: (B)(6) 2017; (B)(6) 2018; RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 7285747 ↗
• InjuryJan 25, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: UNKNOWN; DOR: (B)(6) 2018; UNKNOWN AFFECTED SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 7218116 ↗

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