ATTUNE 1504-00-207Recalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 10603295041221), received between Jun 29, 2017 and Jun 4, 2026 — classified as 1 death, 58 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (14 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 66 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 25395241 ↗
• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24567295 ↗
• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT EXPERIENCED PAIN SO IT WAS DECIDED TO REMOVE EVERYTHING AND REPLACE WITH ATTUNE REVISION COMPONENTS. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 24413871 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24307945 ↗
• MalfunctionJan 22, 2026Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT THE PACKAGING ON THIS ITEM WAS STUCK AND THE IMPLANT COULD NOT BE REMOVED IN A STERILE WAY. ANOTHER DEVICE WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24147503 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A STAGE 1 KNEE REVISION. THEY PUT IN A TEMPORARY ANTIBIOTIC SPACER. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24078297 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION AND SPACER WAS PLACED FOR INFECTION. NO FURTHER INFORMATION IS AVAILABLE. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23583062 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2021. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 22027408 ↗
• MalfunctionMay 9, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT THE LIFTING TAB ON THE INNER BLISTER LID BECAME DETACHED AND THEREFORE IT WAS NOT POSSIBLE TO TRANSFER THE INNER BLISTER CONTAINING THE IMPLANT INTO THE STERILE FIELD. ANOTHER IMPLANT WAS OPENED FOR USE. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21997736 ↗
• InjuryFeb 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAINFUL LATERALLY UNSTABLE SWOLLEN RIGHT KNEE. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 21298499 ↗
• InjuryOct 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: ON (B)(6) 2024, THE PATIENT HAD A VISIT WITH THE PHYSICIAN ASSISTANT 5 MONTHS OUT FROM RECEIVING BILATERAL KNEE REPLACEMENTS. THE PATIENT¿S RIGHT KNEE IS NOW PAINFUL AND DOESN¿T FEEL LIKE IT IS IMPROVING. A LOT OF SYNOVITIS, THICKENED SYNOVIUM AND FLUID IN THE KNEE WAS IDENTIFIED. ON (B)(6) 2024, THE PATIENT RETURNS TO THE SURGEON. ON XRAY THERE IS RESORPTION IN TIBIA ZONE 1 AND THE POSTERIOR FLANGE OF THE FEMUR. THE SURGEON SUSPECTS A CHRONIC LOW-GRADE INFECTION. HE PLANS TO EITHER PERFORM A 1-STAGE REVISION OR EXPLANT WITH A TEMPORARY ANTIBIOTIC SPACER DEPENDENT ON WHAT THE CULTURES GROW WITHIN THE NEXT COUPLE WEEKS.

  Patient problems: Extraskeletal ossification; Fluid Discharge; Pain; Synovitis; Unspecified Infection

  MAUDE report 20421186 ↗
• InjuryJul 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAS A LONG HISTORY OF INFECTION. FEMUR, TIBIA, TIBIA POLY INSERT AND PATELLA WERE REMOVED BECAUSE OF INFECTION. TIBIA POLY WAS EXCHANGES (B)(6) 2023 BECAUSE OF INFECTION. DOI- (B)(6), 2023 DOR- (B)(6) 2024 AFFECTED SIDE- RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 19782097 ↗
• MalfunctionMay 2, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  THE SURGEON SENT A MIR 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 19228321 ↗
• InjuryMar 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED FOR INSTABILITY. THERE WERE NO SURGICAL DELAYS OR HARM TO PATIENT. NO BROKEN INSTRUMENTS. DOI: (B)(6) 2022, DOR: (B)(6) 2024, AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 18913742 ↗
• DeathFeb 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). ASSOCIATED STUDY: REGISTRY, DATE OF EVALUATION: (B)(6) 2024, DATE OF ONSET: 25/JAN/2024, DIAGNOSIS: DEATH, COUNTRY: US, SERIOUS: YES, DEVICE RELATED: DEFINITELY NOT, PROCEDURE RELATED: REMOTE POSSIBILITY, SUBJECT'S AGE AT ENROLLMENT: 78, SUBJECT'S GENDER: MALE, SUBJECT'S HEIGHT: 70 IN, SUBJECT'S WEIGHT: 142 LBS. (B)(4) ARE RELATED TO EACH OTHER. BOTH COMPLAINTS ARE CREATED FOR THE BILATERAL KNEES. (B)(4) CAPTURE THE LEFT KNEE. (B)(4) CAPTURE THE RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18747645 ↗
• 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 (B)(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 CEMEN

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

  MAUDE report 18371981 ↗
• InjuryNov 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAS A STIFF KNEE. SURGEON REVISED AN ATTUNE MS TO A CRS. CASE WENT WELL. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 18220879 ↗
• InjuryMar 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 16545852 ↗
• InjuryFeb 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A SEVERE LAXITY. IT WAS SUSPECTED AS PCL DEFICIENCY. ATTUNE IMPLANTS WERE REMOVED. LIGAMENTS AND STABILITY WERE VERY COMPROMISED. S-ROM NOILES HINGE WAS IMPLANTED. NOW, IT WAS WELL BALANCED AND STABLE. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2018. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 16375182 ↗
• InjuryJan 18, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMORAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT FULL REVISION KNEE SURGERY DUE TO PAIN. FEMORAL COMPONENT WAS FOUND TO BE LOOSE DURING SURGERY. THE LOOSENING INTERFACE WAS CEMENT TO IMPLANT. REVISED WITH ATTUNE REVISION COMPONENTS WITH SLEEVES AND STEM ON BOTH FEMORAL AND TIBIAL ANATOMY. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 16194488 ↗
• InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO AN INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15816062 ↗
• InjuryNov 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE SURGERY FOR OA VIA TKA WITH THE IMPLANTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE PATIENT HAD INFECTION. THEN, THE REVISION WAS DONE, AND IMPLANTS WERE REMOVED ON (B)(6) 2022. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 15751310 ↗
• InjurySep 8, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS AT THE CEMENT TO IMPLANT INTERFACE. TWO DEPUY CEMENTS WERE USED. DOI: (B)(6) 2021, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 15381200 ↗
• InjuryAug 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXHIBITED PAIN AND SWELLING. SURGEON DID WORK UP FOR INFECTION, DETERMINED IMPLANT NEEDED TO BE EXPLANTED ON FAVOR OF ANTIBIOTIC SPACER. DOI: (B)(6) 2021, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 15234382 ↗
• InjuryFeb 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR HYPEREXTENSION FLEXION OF 70 DEGREES. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT HAS A CAUSAL RELATIONSHIP TO DEVICE AND CAUSAL RELATIONSHIP TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021. DATE OF EVENT (ONSET): (B)(6) 2022. (RIGHT KNEE). TREATMENT: MANIPULATION UNDER ANESTHESIA.

  Patient problems: Adhesion(s); Loss of Range of Motion

  MAUDE report 13560956 ↗