ATTUNE 1506-00-007Recalls & reported problems

Summary

The FDA's MAUDE database contains 288 adverse event reports that list this exact device (DI 10603295042419), received between Jun 27, 2017 and Jun 4, 2026 — classified as 283 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (215 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 288 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING AND INFECTION. THERE WAS LOOSENING OF THE FEMUR AND TIBIA. THE CEMENT MANUFACTURER WAS UNKNOWN. NO LOT NUMBERS ARE AVAILABLE. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25395204 ↗
• InjuryFeb 10, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING COMPONENTS AT THE CEMENT IMPLANT INTERFACE. CEMENT MANUFACTURER: UNKNOWN. DOI: (B)(6) 2016. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 24306856 ↗
• InjuryNov 6, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO TIBIA AND FEMUR LOOSENING AT THE IMPLANT CEMENT INTERFACE. DOI (B)(6) 2014, DOR (B)(6) 2025, AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23485154 ↗
• InjuryOct 24, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO FEMUR AND TIBIA LOOSENING AT THE IMPLANT CEMENT INTERFACE. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23380825 ↗
• InjuryJul 31, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE REVISION OF AN ATTUNE DUE TO A LOOSE TIBIA WAS PERFORMED. SURGEON SAID IT WAS A VERY WELL-BALANCED KNEE, POLY INSERT DID NOT HAVE ANY WEAR AND SURGEON SAID, 'IT STILL LOOKS NEW', BUT THE PATIENT DOES HAVE RHEUMATOID ARTHRITIS AND INDICATED THAT THIS MAY BE A REASON BEHIND THE LOOSENING. THE FEMORAL COMPONENT WAS WELL FIXED. THE PATELLA COMPONENT WAS WELL FIXED (AND NOT REVISED). THE TIBIA WAS VERY LOOSE AND DID NOT TAKE MUCH AT ALL TO EXTRACT. THE SURGEON THEN ASKED IF THIS WAS OUR OLD TIBIA BEFORE S+ WHICH I CONFIRMED IT WAS. IT CAME OUT CLEAN AS I HAVE SEEN MULTIPLE TIMES BEFORE, WITH NO CEMENT AT ALL ON THE TIBIAL COMPONENT RIGHT SIDE. THEY ALSO HAD THEIR LEFT SIDE DONE (UNSURE WHEN) BUT THEY WILL MONITOR THIS SIDE TOO.

  Patient problems: Rheumatoid Arthritis

  MAUDE report 22674331 ↗
• InjuryMay 27, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE REVISION TO TREAT PAIN AND JOINT INSTABILITY SECONDARY TO ASEPTIC LOOSENING OF THE TIBIAL TRAY. UPON ENTERING THE JOINT, THE TIBIAL TRAY WAS FOUND TO BE LOOSENED AND DEBOUNDED AT THE COMPETITOR CEMENT TO IMPLANT INTERFACE. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE FEMORAL COMPONENT AND PATELLA WERE WELL-FIXED AND RETAINED. THE PATIENT RECEIVED AN ATTUNE REVISION CONSTRUCT SECURED WITH COMPETITOR CEMENT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS.

  Patient problems: Joint Laxity; Pain

  MAUDE report 22087743 ↗
• InjuryMay 8, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION OF AN ATTUNE CRFB CONSTRUCT DUE TO TIBIAL LOOSENING. FEMUR WAS WELL FIXED. FIRST GENERATING ATTUNE TIBIA. TIBIAL BASEPLATE CAME OUT CLEAN WITH MINIMAL EFFORT TO EXTRACT, AND WITH NO CEMENT ATTACHED TO THE IMPLANT. CEMENT-BONE INTERFACE WAS SOUND. FEMUR WAS WELL FIXED WITH EXCELLENT IMPLANT-CEMENT INTERFACE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Insufficient Information

  MAUDE report 21985485 ↗
• InjuryMar 21, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT UNDERWENT TKA REVISION DUE TO LOOSENING OF THE CEMENT AND IMPLANTS. LOOSENING OCCURRED AT THE CEMENT/IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21665772 ↗
• InjuryMar 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A DENTAL PROCEDURE RECENTLY AND THEN HE GOT AN INFECTION IN HIS KNEE. COMPONENTS WERE REMOVED. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21546817 ↗
• InjuryFeb 20, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS DOING WELL UNTIL ABOUT THREE MONTHS AGO. STARTING FEELING SOME DISCOMFORT IN THEIR LEFT KNEE. X-RAYS SHOWED A LOOSE TIBIAL COMPONENT AT CEMENT TO IMPLANT INTERFACE NO TRAUMATIC EXPERIENCE HAD OCCURRED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Discomfort

  MAUDE report 21425815 ↗
• InjuryNov 13, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  DOI: (B)(6) 2015: MALE PATIENT RECEIVED AN ATTUNE RIGHT TKA TO TREAT OA. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOR: (B)(6) 2021: 67 YEAR-OLD MALE PATIENT RECEIVED A RIGHT ATTUNE TOTAL KNEE REVISION TO TREAT PAIN SECONDARY TO LOOSENING OF THE TIBIAL TRAY. UPON ENTERING THE JOINT, THE SURGEON EXPRESSED A SMALL EFFUSION AND DEBRIDED SYNOVITIS. THE TIBIAL TRAY WAS GROSSLY LOOSE AND DEBONDED AT COMPETITOR CEMENT TO IMPLANT INTERFACE AND REVISED. THE FEMORAL COMPONENT WAS WELL-FIXED BUT REVISED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE PATELLA WAS WELL-FIXED AND RETAINED. THE PATIENT RECEIVED A COMPETITOR REVISION TIBIAL CONSTRUCT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2015. DOR: (B)(6) 2021. RIGHT KNEE.

  Patient problems: Pain; Swelling/ Edema; Synovitis

  MAUDE report 20673741 ↗
• InjuryNov 11, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT ON (B)(6) 2014, PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY DUE TO COMPLAINTS OF CHRONIC LEFT KNEE PAIN AND WAS EVALUATED TO HAVE AN END-STAGE OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS ON (B)(6) 2021, PATIENT UNDERWENT A TOTAL LEFT KNEE REVISION TO TREAT PAIN SECONDARY TO LOOSENING OF THE TIBIAL TRAY. UPON ENTERING THE JOINT, THE SURGEON CONFIRMED LOOSENING OF THE TIBIAL TRAY AT THE CEMENT TO IMPLANT INTERFACE. THE TIBIAL TRAY WAS GROSSLY LOOSE AND DEBONDED AT COMPETITOR CEMENT TO IMPLANT INTERFACE AND REVISED. THE FEMORAL COMPONENT WAS WELL-FIXED BUT REVISED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE PATELLA WAS WELL-FIXED AND RETAINED. THE PATIENT RECEIVED A COMPETITOR REVISION TIBIAL CONSTRUCT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2014, DOR: (B)(6) 2021 LEFT KNEE.

  Patient problems: Pain

  MAUDE report 20658302 ↗
• InjuryOct 22, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT THERE WAS NO INFORMATION ABOUT CEMENT.

  Patient problems: Insufficient Information

  MAUDE report 20505938 ↗
• InjurySep 25, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO TIBIAL LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. IMPLANTS WERE EXPLANTED. CEMENT MANUFACTURER WAS UNKNOWN. DOI: UNKNOWN. DOR:(B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 20301490 ↗
• InjuryJul 2, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  ADDITIONAL INFORMATION WAS RECEIVED. WAS THERE ANY ALLEGATION AGAINST THE FEMUR AND INSERT? FEMUR, PARTIAL LOOSENING SUSPECTED. WHAT IS THE AFFECTED SIDE INVOLVED IN THIS EVENT? LEFT.

  Patient problems: Pain

  MAUDE report 19656800 ↗
• MalfunctionMay 2, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  THE SURGEON SENT A MIR ON 04-22-2024. HE ASKED IF THERE ARE REPORTS OF INCREASED EARLY LOOSENING RATES FOR THE FOLLOWING PRODUCTS: 150600007 LOT:8950471; 150400207 LOT: 9090157; 151620706 LOT: HX5898; HE ATTACHED AN IMPLANT-PASS WITH THOSE NUMBERS.

  Patient problems: Insufficient Information

  MAUDE report 19228333 ↗
• InjuryFeb 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INSTABILITY AND NEEDED A REVISION. DOR: (B)(6) 2024 AFFECTED SIDE: LEFT KNEE

  Patient problems: Joint Laxity

  MAUDE report 18711108 ↗
• InjuryDec 21, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  LITIGATION COMPLAINT RECEIVED AD 7 DEC 2023. MEDICAL RECORDS REVIEW ((B)(4) MEDICAL RECORDS AD 7 DEC 2023): ON (B)(6) 2015, THE PATIENT RECEIVED AN ATTUNE RIGHT TOTAL KNEE REPLACEMENT, FOR END-STAGE OSTEOARTHRITIS, UTILIZING SIZE 7 FEMUR, SIZE 7 TIBIAL TRAY, SIZE 7 BY 7.5MM THICK INSERT, AND 41MM PATELLA IMPLANTS, WITH COMPETITOR ANTIBIOTIC BONE CEMENT. HE HAD NO COMPLICATIONS. PRIMARY IMPLANTS ON PAGE 8 OF MEDICAL RECORDS. PATIENT PROGRESSED WELL UNTIL HE BEGAN TO EXPERIENCE PERSISTENT PAIN, STIFFNESS, LOCKING AND CHRONIC SWELLING IN (B)(6) 2021. X-RAYS REVEALED LUCENCY BEHIND FEMUR AND TIBIAL COMPONENTS. REVIEW OF HIS BONE SCAN OF THE RIGHT KNEE ON DECEMBER 6, 2012 REVEALED APPARENT LOOSENING OF THE FEMUR COMPONENT. PLANS WERE MADE FOR A REVISION OF THE RIGHT KNEE. RIGHT KNEE WAS REVISED ON (B)(6) 2022, TO ADDRESS PAIN, SWELLING, STIFFNESS, MID-FLEXION AND VARUS-VALGUS JOINT INSTABILITY, AND FEMORAL IMPLANT LOOSENING (AT UNSPECIFIED INTERFACE), WITH REVISION OF THE FEMUR, TIBIAL TRAY, PATELLA AND INSERT COMPONENTS. IT WAS NOTED THAT NEITHER THE FEMUR OR TIBIAL TRAY COMPONENTS REMOVED HAD MUCH IN THE WAY OF ANY CEMENT ADHERED TO THE IMPLANTS, THAT THEY CAME OUT RELATIVELY FREE OF

  Patient problems: Joint Laxity; Muscular Rigidity; Pain; Swelling/ Edema

  MAUDE report 18371976 ↗
• InjuryAug 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THE DECISION WAS MADE TO REMOVE ALL COMPONENTS AND REVISE HIS KNEE IN A ONE STAGE, DUAL SET UP REVISION WITH PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17563405 ↗
• InjuryJul 20, 2023Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  IT WAS REPORTED THAT ATTUNE PS FB WITH TIBIAL TRAY MEDIAL COLLAPSED AND LOOSENED. THERE WAS NO SURGICAL DELAY. DOI: 2013. DOR: JULY 6, 2023 AFFECTED SIDE: (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 17360651 ↗
• InjuryMar 28, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  MALE PATIENT RECEIVED A RIGHT ATTUNE TKA TO TREAT PAIN, OSTEOARTHRITIS, A TORN MENISCUS, AND DJD. THE PATELLA WAS RESURFACED AND COMPETITOR CEMENT X 2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. MALE PATIENT RECEIVED A RIGHT KNEE REVISION TO TREAT PERSISTENT PAIN SECONDARY TO ASEPTIC LOOSENING. UPON ENTERING THE JOINT, THE SURGEON DEBRIDED PERIARTICULAR INFLAMMATORY TISSUE AND SENT IT TO PATHOLOGY. THE PATHOLOGY REPORT IDENTIFIED SYNOVITIS, ARTHROFIBROSIS, AND GIANT FOREIGN BODY REACTIVE CELLS. THE TIBIAL TRAY WAS GROSSLY LOOSE AND DEBONDED AT THE CEMENT TO IMPLANT INTERFACE AND REVISED. THE FEMORAL COMPONENT WAS WELL-FIXED BUT REVISED TO ACCOMMODATE THE REVISION CONSTRUCT. THE PATELLA WAS WELL-FIXED AND RETAINED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE PATIENT RECEIVED A COMPETITOR REVISION CONSTRUCT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2017, DOR: (B)(6) 2022, RIGHT KNEE.

  Patient problems: Adhesion(s); Foreign Body Reaction; Pain; Synovitis

  MAUDE report 16626976 ↗
• InjuryMar 15, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  MEDICAL RECORDS RECEIVED. ON (B)(6) 2015, THE PATIENT HAD A RIGHT KNEE ARTHROPLASTY TO ADDRESS ARTHRITIS. DEPUY COMPONENTS ALONG WITH COMPETITOR CEMENT WAS IMPLANTED DURING THE PROCEDURE. ON (B)(6) 2022, THE PATIENT HAD A REVISION RIGHT TOTAL KNEE TO ADDRESS FAILED RIGHT TOTAL KNEE. THE INDICATIONS FOR SURGERY INCLUDED PERSISTENT PAIN, SUSPICION FOR INFECTION WITH INFLAMMATORY MARKERS AND ASPIRATION; HOWEVER, IMAGING CONSISTENT WITH ASEPTIC LOOSENING OF THE TIBIAL COMPONENT. DURING THE PROCEDURE, THE SURGEON OBSERVED SOME GRAYISH STAINING OF THE TISSUE CONSISTENT WITH SOME MECHANICAL MOTION OF THE COMPONENTS. TIBIAL COMPONENT POPPED FREE FROM CEMENT CONSISTENT WITH LOOSENING SEEN CONSISTENTLY WITH FIRST GENERATION ATTUNE TIBIAS. DEPUY COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE INCLUDING DEPUY CEMENT.

  Patient problems: Adhesion(s); Foreign Body Reaction; Joint Laxity; Pain; Synovitis; Unspecified Infection; Unspecified Musculoskeletal problem; Unspecified Tissue Injury

  MAUDE report 16546002 ↗
• InjuryOct 30, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION COMPLETED DUE TO TIBIAL BASE PLATE LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. IT WAS ALSO REPORTED THAT PATELLAR TENDON WAS RUPTURED. PATELLAR, TIBIAL BASE PLATE AND INSERT IMPLANTS WERE REMOVED. DOI: (B)(6) 2017. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 15697608 ↗
• InjuryJul 6, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE TIBIAL TRAY AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. TIBIAL TRAY WAS REMOVED AND REVISED WITH AN ATTUNE REVISION RP TRAY, 37 TIBIAL SLEEVE AND 16X60 TIBIAL STEM. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2015. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 14935628 ↗
• InjuryJul 5, 2022Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  REVISION OF ATTUNE KNEE DUE TO A LOOSE AND SUBSIDED TIBIAL TRAY. DOI: (B)(6) 2016. DOR: (B)(6) 2022. UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 14914348 ↗