ATTUNE 1511-01-104Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295436515), received between Apr 17, 2019 and Dec 5, 2025 — classified as 15 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD STATIC SPACER PLACED DUE TO INFECTION. INFECTION CLEARED VIA ASPIRATION. PATIENT CONVERTED TO DISTAL FEMORAL REPLACEMENT UNEVENTFULLY. THERE WAS NO PATIENT HARM AND NO DELAY NOTED. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23730115 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AS ASPIRATION POST SPACER AND WAS FOUND TO NOW BE GROWING YEAST. SURGEON CHOSE TO REPLACE THE EXISTING SPACER AND TREAT FOR YEAST. ALL COMPONENTS WERE FOUND TO BE INGROWN, DESPITE THE PRESENCE OF YEAST. ALL WERE REMOVED AND NEW COMPONENTS WERE PLACED WITH ANTIBIOTIC CEMENT AND RESORBABLE BEADS TO ADDRESS YEAST. UPON INSERTING THE NEW COMPONENTS ON THE FEMORAL SIDE, A FRACTURE WAS NOTED, DESPITE A CABLE BEING PLACED PRIOR TO PREP AND INSERTION. COMPONENTS WERE EXCHANGED AND A LONGER STEM AND AN ADDITIONAL CABLE WAS PLACED TO ADDRESS THE FRACTURE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE. THIS REPORT IS RELATED (B)(4), WHICH CAPTURES THE FRACTURE DURING INSERTION OF NEW DEVICES.

  Patient problems: Unspecified Infection

  MAUDE report 23697813 ↗
• InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT UNFORTUNATELY, THE PATIENT WAS STILL INFECTED AND DRAINED SO THE SPACER WAS BEING EXCHANGED IN HOPES TO CLEAR THE INFECTION. NO DELAY NOR PATIENT HARM WAS NOTED.

  Patient problems: Unspecified Infection

  MAUDE report 23592635 ↗
• InjuryNov 3, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ ASEPTIC LOOSENING DATE OF EVENT: 06 OCT 2025. DATE OF REVISION: (B)(6) 2025. TREATMENT/IMPACT: REVISION, COMPONENTS REMOVED (FEMORAL, INSERT, TIBIAL), SYNOVECTOMY.

  Patient problems: Insufficient Information

  MAUDE report 23452545 ↗
• InjurySep 20, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT CAME BACK IN TO SEE DOCTOR WITH REDNESS (HOTNESS) AND PAIN IN PATIENT'S (B)(6). AFTER TESTING THEY DETERMINED THE KNEE TO BE SEPTIC AND A REVISION WAS NEEDED. UPON OPENING THE JOINT THE COMPONENTS APPEARED TO BE LOOSE AND THERE WAS BONE LOSS BETWEEN THE CEMENT MANTLE AND THE BONE. THE COMPONENTS WERE REMOVED, THE JOINT WAS THOROUGHLY IRRIGATED AND THE CANALS WERE REAMED OUT. AFTERWARDS NEW REVISION COMPONENTS WERE PLACED WITH ANTIBIOTIC CEMENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Erythema; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 20267198 ↗
• InjuryJun 28, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT X-RAYS SHOW PROGRESSIVE LUCENT LINES AND CONTINUES TO COMPLAIN OF PAIN. A POLY EXCHANGE WAS PERFORMED ON 6-8-2023 AND A DER WAS SUBMITTED. THE FEMORAL COMPONENT WAS REMOVED WITH EASE AND CEMENT HAD NOT ADHERED TO THE BONE. HOWEVER THE FEMORAL SLEEVE WAS INGROWN AND HAD TO REMOVED UTILIZING SIGNIFICANT EFFORT. THE TIBIAL TRAY WAS WELL FIXED, HOWEVER THE TIBIAL SLEEVE ONLY SHOWED FIBROUS TISSUE, INDICATING THAT IT WAS LOOSE. THE PATELLA WAS ALSO REMOVED QUITE EASILY. THE SURGEON ROUTINELY UTILIZES DEPUY 2 WITH GENT FOR HIS REVISION PROCEDURES, HOWEVER IT IS HOSPITAL OWNED SO NOT IN ANY OF MY RECORDS. A FULL REVISION OFF ALL COMPONENTS WAS PREFORMED WITH NO DELAY NOR PATIENT HARM. NO WEAR WAS NOTED AND ALL COMPONENTS WERE APPROPRIATELY SIZED AND ALIGNED. DOI: (B)(6), 2022 DOR: (B)(6), 2024 AFFECTED SIDE: LEFT KNEE. (B)(4) CREATED FOR 8TH JUN 2023 REVISION.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 19632910 ↗
• InjuryDec 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A REVISION KNEE REPLACEMENT IN 2022 DUE TO INFECTION. THE PATIENT PRESENTED TO THE CLINIC AGAIN IN FALL 2023. A FURTHER REVISION DUE TO AN INFECTION IS PLANNED FOR (B)(6) 2024. A SEPARATE COMPLAINT FOR THE FIRST REVISION WAS FILED UNDER (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18414099 ↗
• InjuryMar 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON WAS USING THE ATTUNE REVISION UNDER THE SUPERVISION OF CB AND MG FROM DPS RECON. THE SYSTEM WAS BEING USED FOR THE SECOND STAGE OF AN INFECTED KNEE ARTHROPLASTY. UNINTENTIONAL OUTCOME: PREPARATION OF THE IMPLANT, APPROACH, BONE CUTS, TRIALLING ETC WENT AS PLANNED. ON INTRODUCTION AND IMPACTION OF THE DEFINITIVE FEMORAL IMPLANT A SMALL CRACK OF THE ANTERIOR CORTEX OF THE FEMUR WAS DETECTED TOWARDS THE END OF THE CASE. THIS DELAYED THE CASE BY A FURTHER 30MINUTES WHILST 2 X CERCLAGE CABLES WERE APPLIED TO THE FEMUR. THIS HAPPENED AT APPROXIMATE 3PM. I AM IN THE PROCESS OF CHASING THE HOSPITAL FOR THE LOT DETAILS OF THE DEFINITIVE IMPLANTS.

  Patient problems: Limb Fracture

  MAUDE report 11444379 ↗
• InjuryDec 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ANEMIA- POST OP IRON SUBSTITUTION EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY NOT RELATED TO BOTH DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020; DATE OF EVENT (ONSET): (B)(6) 2020; (RIGHT KNEE). TREATMENT: INJECTED MEDICATION (UNSPECIFIED).

  Patient problems: Anemia

  MAUDE report 10924769 ↗
• InjuryMar 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FEMORAL FRACTURE DURING ATTUNE REVISION IMPLANTATION. ALL SURGICAL STEPS FOLLOWED. CABLE APPLIED TO THE FEMUR. SURGICAL DELAY OF 10 MINUTES.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 9825611 ↗
• InjuryMar 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PAIN AND STIFFNESS OF THE KNEE. 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) 2018; DATE OF EVENT (ONSET): (B)(6) 2019; (RIGHT KNEE).

  Patient problems: Muscular Rigidity; No Code Available; Pain

  MAUDE report 9811075 ↗
• MalfunctionMar 3, 2020Difficult to Insert; Difficult to Insert

  ATTUNE REVISION - WHEN WE CAME TO ASSEMBLE IMPLANT IT BECAME APPARENT THAT THE 40MM SLEEVE WOULD NOT FIT ON A SIZE 3 CRS FEMUR. WE HAD TO DOWNSIZE THE SLEEVE TO A 35MM TO ACCOMMODATE THE ASSEMBLY. THIS PARTIALLY COATED IMPLANT WAS THEN CEMENTED IN TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9781612 ↗
• InjuryJan 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR SPLIT OF ANTERIOR FEMUR : BONE FRACTURE - FEMORAL (INTRAOPERATIVE, RE-IMPLANTATION) EVENT IS SERIOUS AND IS CONSIDERED MODERATE EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT (ONSET): (B)(6) 2019 (LEFT KNEE). DEPUY COMPONENTS IMPLANTED (B)(6) 2019: CATALOG ID: 151710622, LOT: 8613688, DESCRIPTION: ATTUNE REVISION CRS ROTATING PLATFORM INSERT SIZE 6 22 MM. CATALOG ID: 154706002, LOT: HZ2103, DESCRIPTION: ATTUNE REVISION DISTAL FEMORAL AUGMENT SIZE 6 8MM. CATALOG ID: 154706002, LOT: HZ2103, DESCRIPTION: ATTUNE REVISION DISTAL FEMORAL AUGMENT SIZE 6 8MM. CATALOG ID: 154906002 , LOT: J36Y75, DESCRIPTION: ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SIZE 6 8 MM. CATALOG ID: 150660006, LOT: 9213508, DESCRIPTION: ATTUNE REVISION TIBIAL BASE ROTATING PLATFORM SIZE 6 CEMENTED. CATALOG ID: 150440106, LOT: J5753J, DESCRIPTION: ATTUNE REVISION CRS FEMORAL SIZE 6 LEFT CEMENTED. CATALOG ID: 151111202, LOT: J35W45, DESCRIPTION: ATTUNE REVISION TIBIAL SLEEVE POROCOAT FULLY COATED 37 MM. CATALOG ID: 154905001, LOT: J2401D, DESCRIPTION: ATTUNE REVISION POSTERIOR FEMORAL AUGME

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 9557542 ↗
• InjuryNov 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: UPDATED: CLINICAL ADVERSE EVENT RECEIVED FOR JOINT STIFFNESS DEVICE AND PROCEDURE (RELATEDNESS): DEVICE RELATED: DEFINITELY NOT PROCEDURE RELATED: PROBABLY DATE OF EVENT: 22-OCT-2019.

  Patient problems: Muscular Rigidity; No Code Available

  MAUDE report 9328409 ↗
• InjuryApr 17, 2019No Apparent Adverse Event; No Apparent Adverse Event

  PATIENT WAS TREATED WITH A SURGICAL IRRIGATION & DEBRIDEMENT, WITH NO REVISION OF PRODUCTS.

  Patient problems: Hematoma; No Code Available

  MAUDE report 8524375 ↗
• InjuryApr 17, 2019No Apparent Adverse Event; No Apparent Adverse Event

  PATIENT WAS TREATED WITH A SURGICAL IRRIGATION & DEBRIDEMENT, WITH NO REVISION OF PRODUCTS.

  Patient problems: Hematoma; No Code Available

  MAUDE report 8524280 ↗