ATTUNE 1506-10-005Recalls & reported problems

Summary

The FDA's MAUDE database contains 442 adverse event reports that list this exact device (DI 10603295042594), received between Jul 5, 2017 and Sep 28, 2026 — classified as 441 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (344 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 442 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Loss of or Failure to Bond

  Patient problems: Joint Laxity

  MAUDE report 50921575 ↗
• InjuryAug 3, 2026Loss of or Failure to Bond

  It was reported that there was a Revision of an Attune PSRP construct which was implanted on the patient's right side. Reason for revision was due to tibial loosening. There was no surgical delay.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50113796 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6), STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR RIGHT KNEE ARTHROPLASTY INFLAMMATORY REACTION TO METAL DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: POSSIBLY RELATED. PROCEDURE RELATED: POSSIBLY RELATED. DATE OF EVENT: 13 DEC 2018. DATE OF IMPLANT: (B)(6) 2014. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: RESULTED IN A MEDICAL OR SURGICAL INTERVENTION, SURGICAL TREATMENT OF STUDY KNEE (DATE: (B)(6) 2019), COMPONENTS REMOVED (FEMORAL COMPONENT; TIBIAL BASE).

  Patient problems: Hypersensitivity/Allergic reaction; Inflammation

  MAUDE report 23929019 ↗
• InjuryNov 4, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q3 OF 2025. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION DUE TO LOOSE TIBIAL TRAY, POLY WEAR, AND PAIN. THE NON-ARTICULAR SURFACE OF THE CEMENTED TIBIAL TRAY SHOWS NO CEMENT REMAINING. CEMENT MFG IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 23468627 ↗
• InjuryApr 21, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR IMPLANT LOOSENING DUE TO BREAKDOWN OF BONDING BETWEEN CEMENT AND TRAY INTERFACE. THERE WAS NO DELAY IN SURGERY. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21872620 ↗
• InjuryApr 3, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT'S TIBIAL BONE HAD COLLAPSED. SURGEON DECIDED TO REVISE ALL COMPONENTS WITH SLEEVES AND STEMS. NOTHING WAS SAID ABOUT PROBLEMS WITH THE COMPONENTS JUST THAT THE TIBIAL BONE WAS VERY SOFT. TIME WAS NOT EXTENDED DUE TO ANY OF THE PRODUCTS. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21762497 ↗
• InjuryMar 20, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIA AND FEMUR AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21655093 ↗
• InjuryJan 28, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIA AT UNKNOWN INTERFACE. SURGEON REVISED THE TIBIA TO AN RP CRS WITH CEMENTED STEMS AND A 10MM RM WEDGE. THE FEMUR WAS WELL FIXED, SO HE LEFT THAT AND USED AN RPPS POLY. NO FURTHER PATIENT INFORMATION IS AVAILABLE AT THIS TIME. CEMENT MANUFACTURER WAS UNKNOWN. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21252317 ↗
• InjuryJan 24, 2025Loss of or Failure to Bond; Noise, Audible; Loss of or Failure to Bond; Noise, Audible

  ON (B)(6)2018, THE PATIENT UNDERWENT A PRIMARY RIGHT KNEE REPLACEMENT USING ATTUNE IMPLANTS INCLUDING A PATELLA AND SMARTSET BONE CEMENT. ON (B)(6)-2018, SHE EXPERIENCED A NEW ONSET OF RIGHT KNEE PAIN AFTER DOING SOME HOUSE CLEANING. SHE STATES THERE IS A LOT OF CLICKING AND STIFFNESS AS WELL. PHYSICAL THERAPY IS ORDERED. ON (B)(6)2024, THE PATIENT HAS A RIGHT KNEE BONE SCAN REVEALING SUSPECTED LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS. ON (B)(6)2024, THE PATIENT UNDERWENT A RIGHT KNEE REVISION. INTRAOPERATIVELY THERE WAS SCAR TISSUE, EXTENSIVE SYNOVITIS, AND THE TIBIAL COMPONENT WAS CONFIRMED TO BE LOOSE AT THE IMPLANT TO CEMENT INTERFACE. THE FEMORAL COMPONENT WAS WELL FIXED. THE PATIENT WAS REVISED TO COMPETITOR IMPLANTS THOUGH THE PATELLA WAS LEFT IN SITU. DOI: (B)(6), 2018. DOR: (B)(6) 2024. RIGHT KNEE.

  Patient problems: Adhesion(s); Muscular Rigidity; Pain; Synovitis

  MAUDE report 21228500 ↗
• InjuryJan 22, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING. ALL IMPLANTS WERE LOOSE AT THE CEMENT/IMPLANT INTERFACE AND DEPUY CEMENT WAS USED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21211275 ↗
• InjuryNov 13, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT A LEFT TKA DUE TO ARTHRITIS. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X2 WAS USED. THERE WERE NO COMPLICATIONS NOTED. ON (B)(6) 2021, THE PATIENT UNDERWENT A REVISION OF THE LEFT TKA DUE TO FAILED KNEE. THE TIBIAL COMPONENT WAS NOTED TO LOOSEN AND WAS REMOVED FROM THE CEMENT VERY EASILY. THE FEMORAL COMPONENT, PATELLA, AND INSERT WERE ALSO REVISED, BUT THERE WERE NO ALLEGATIONS REPORTED AGAINST THOSE PRODUCTS. COMPETITOR IMPLANTS AND CEMENT WERE PLACED AT REVISION. DOI: (B)(6) 2016; DOR: (B)(6) 2021; LEFT.

  Patient problems: Insufficient Information

  MAUDE report 20672727 ↗
• InjuryNov 12, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2018, PATIENT REPORTEDLY RECEIVED A LEFT TOTAL KNEE REVISION TO ADDRESS PAIN, FLEXION INSTABILITY, AND ASEPTIC LOOSENING OF THE TIBIAL BASEPLATE. SURGEON IDENTIFIED THAT ALTHOUGH THE FEMUR WAS WELL-FIXED, THE FLEXION INSTABILITY REQUIRED REVISION OF THE FEMUR AND TIBIA. THE TIBIAL TRAY WAS LOOSE--INTERFACE UNSPECIFIED. THE PATELLA WAS FOUND TO BE WELL-FIXED AND WAS RETAINED. FEMUR WAS REPLACED WITH DEPUY ATTUNE REVISION FEMUR SIZE 6, A 30MM SLEEVE, AND 4MM DISTAL AND POSTERIOR AUGMENTS, AND A 14 X 60 FEMORAL STEM. THE TIBIAL TRAY WAS REPLACED WITH AN ATTUNE REVISION TIBIAL TRAY SIZE 6, A 37MM SLEEVE, AND 14 X 60 TIBIAL STEM. THERE WERE NO COMPLICATIONS. DOI: (B)(6) 2015. DOR: (B)(6) 2018. LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 20663660 ↗
• InjuryOct 25, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THERE WAS OSTEOLYTIC CHANGES IN THE PATELLA AND INCREASING PAIN & SWELLING IN PATIENT'S KNEE. TOTAL KNEE REVISION WAS PERFORMED. IT IS UNKNOWN IF THE PATIENT HAD A FALL OR OTHER TRAUMATIC EVENT. ADDITIONALLY, IT WAS REPORTED THAT THERE WAS TIBIAL LOOSENING AT THE CEMENT/IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. THERE WERE NO BROKEN IMPLANTS OR INSTRUMENTS. NO ADVERSE OCCURRENCES TO THE PATIENT. NO SURGICAL DELAY. LOT NUMBERS WERE READ FROM THE SURGICAL FIELD, NO OTHER RECORD IS AVAILABLE. DOI: (B)(6) 2015. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Osteolysis; Pain; Swelling/ Edema

  MAUDE report 20533691 ↗
• MalfunctionJun 13, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  STUDY: DPO 10004 10008 ATTUNE. SUBJECT ID: (B)(6). ADVERSE EVENT: (DIAGNOSIS) SUSPECT LOOSENING TIBIAL COMPONENT (NO RADIOLUCENCIES). DATE OF IMPLANTATION: (B)(6) 2013. DATE OF ONSET: 03 DEC 2015. DATE OF REVISION: NONE. SEVERITY: MODERATE. RELATION TO STUDY DEVICE? DEFINITELY RELATED. RELATION TO STUDY PROCEDURE? POSSIBLY RELATED. TREATMENT: OBSERVATION (NO REVISION AT THIS TIME).

  Patient problems: Insufficient Information

  MAUDE report 19532097 ↗
• InjuryJun 10, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  STUDY: (B)(6). SUBJECT ID: (B)(6). ADVERSE EVENT: (DIAGNOSIS) LOOSE TIBIAL COMPONENT. NO CEMENT ADHERENCE TO IMPLANT DATE OF IMPLANTATION: (B)(6) 2014 DATE OF ONSET: ON (B)(6) 2016 DATE OF REVISION: ON (B)(6) 2016 SEVERITY: SEVERE RELATION TO STUDY DEVICE? DEFINITELY RELATED RELATION TO STUDY PROCEDURE? POSSIBLY RELATED TREATMENT: FEMORAL & TIBIA TRAY/INSERT REVISION; PATELLA RETAINED.

  Patient problems: Insufficient Information

  MAUDE report 19497753 ↗
• InjuryApr 2, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO MISALIGNED TIBIA, UNSTABLE KNEE. DOI: (B)(6) 2015. DOR: (B)(6) 2024. AFFECTED SIDE : RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 19020033 ↗
• InjuryMar 23, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  ADDITIONAL INFORMATION RECEIVED: A. CAN YOU CONFIRM THE PRIMARY SURGERY DATE OR THE ORIGINAL IMPLANTATION DATE? B. IT WAS INDICATED THAT THERE WAS LOOSENING. ON WHAT INTERFACE DID THE LOOSENING OCCUR? C. PLEASE CONFIRM THE MANUFACTURER OF THE CEMENT PRODUCT. IS IT DEPUY MANUFACTURED? ALSO FOR THE QUANTITY USED. D. WAS THERE ANY ALLEGATION AGAINST THE INSERT? RESPONSE/ANSWER: I DO NOT KNOW THE ORIGINAL IMPLANTATION DATE, HOWEVER, IT WAS COMPLETED AROUND 2021. LOOSENING OCCURRED ON THE TIBIA BONE TO TIBIAL BASEPLATE LOOSENING. NO CEMENT WAS STUCK TO THE BOTTOM OF THE IMPLANT. ALL CEMENT WAS STUCK TO THE TIBIA. I DO NOT KNOW WHAT CEMENT THE SURGEON TYPICALLY USED. THERE WAS NO ALLEGATION AGAINST THE INSERT.

  Patient problems: Insufficient Information

  MAUDE report 18966089 ↗
• InjuryMar 4, 2024Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  THE PATIENT UNDERWENT A RIGHT PRIMARY KNEE REPLACEMENT ON (B)(6) 2016 UTILIZING ATTUNE IMPLANTS WITH NO INDICATION OF CEMENT MANUFACTURER. ON (B)(6) 2023, THE PATIENT BEGAN TO HAVE PAIN AND WAS LIMPING. XRAY REVIEW IDENTIFIED GROSS LOOSENING AND EARLY COLLAPSE OF THE RIGHT TIBIA. ON (B)(6) 2023, THE PATIENT WAS REVISED AND THE TRAY WAS CONFIRMED TO BE LOOSE AT THE IMPLANT TO CEMENT INTERFACE. DOI: (B)(6) 2016. DOR: (B)(6) 2023 (RIGHT KNEE).

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Pain; Unspecified Musculoskeletal problem

  MAUDE report 18825094 ↗
• InjuryJan 29, 2024Migration; Migration

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PROXIMAL TIBIA COLLAPSE. REVISION SURGERY WENT WELL, ATTUNE 12 X 110 PRESS FIT STEM, 45 SLEEVE, AND A REVISION TIBIA WAS UTILIZED. PATIENT STATUS/ OUTCOME / CONSEQUENCES -YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? TKA HAD TO BE REVISED, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: YES, IF YES, DESCRIBE: TKA HAD TO BE REVISED. IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN. (B)(4), DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE. (B)(4), DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.- TRUE.

  Patient problems: Insufficient Information

  MAUDE report 18598761 ↗
• InjuryJan 4, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  (B)(6). CLINICAL NOTIFICATION RECEIVED FOR REVISION ASEPTIC LOOSENING. DATE OF IMPLANT: (B)(6) 2017. DATE OF REVISION: (B)(6) 2023 (LEFT KNEE). TREATMENT: FEMORAL COMPONENT, TIBIAL BASE, AND INSERT WERE REVISED.

  Patient problems: Insufficient Information

  MAUDE report 18443354 ↗
• InjuryDec 28, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT'S TIBIA WAS REVISED DUE TO PAIN AND BONE SHOWING UP HOT ON BONE SCAN. SURGEON DID NOT FEEL THAT THE TIBIAL TRAY WAS GROSSLY LOOSE AND DID REQUIRE SOME WORK TO REMOVE. NO CEMENT WAS BONDED TO THE BOTTOM OF THE TRAY. THE SURGEON DID NOTE THAT THE TISSUE AT THE BONE-CEMENT INTERFACE WAS GRAY IN COLOR AND HE FELT THE DISCOLORATION WAS THE RESULT OF MICROMOTION. THERE WAS NO DELAY IN SURGERY. DOI: (B)(6) 2015. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 18409097 ↗
• InjuryOct 11, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT UNDERWENT AN ATTUNE RPPS CONSTRUCT UTILIZING THE PRE S+ ATTUNE TIBIA WITH NO UNDERSIDE POCKETS. RECENTLY SHE WAS EXPERIENCING PAIN IN HER KNEE. UPON OPENING HER KNEE IT WAS DISCOVERED THAT HER TIBIAL WAS LOOSE. THE FEMUR AND INSERT WERE REMOVED AS WELL. THE PATELLA COMPONENT WAS RETAINED AND A FULL ATTUNE CRS REVISION CONSTRUCT WAS PLACED. SHE IS NOT CONFIRMED FOR INFECTION. DOI: (B)(6) 2015, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 17916525 ↗
• InjuryOct 11, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT UNDERWENT AN ATTUNE RPPS CONSTRUCT UTILIZING THE PRE S+ ATTUNE TIBIA WITH NO UNDERSIDE POCKETS. RECENTLY SHE WAS EXPERIENCING PAIN IN HER KNEE. UPON OPENING HER KNEE IT WAS DISCOVERED THAT HER TIBIAL WAS LOOSE. THE FEMUR AND INSERT WERE REMOVED AS WELL. THE PATELLA COMPONENT WAS RETAINED AND A FULL ATTUNE CRS REVISION CONSTRUCT WAS PLACED. SHE IS NOT CONFIRMED FOR INFECTION. DOI: (B)(6) 2015, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 17916413 ↗
• InjurySep 26, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO PAIN AND LOOSENING OF TIBIA AT UNKNOWN INTERFACE. DOI: UNKNOWN . DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 17816168 ↗
• InjurySep 6, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT/IMPLANT INTERFACE. DEPUY CEMENT WAS USED. DOI: (B)(6) 2016. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 17689844 ↗