ATTUNE 1506-10-007Recalls & reported problems

Summary

The FDA's MAUDE database contains 284 adverse event reports that list this exact device (DI 10603295042617), received between Jul 13, 2017 and Oct 15, 2025 — classified as 283 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (214 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 25 most recent of 284 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  SUBJECT ID: (B)(6), STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR FAILURE OF LEFT TOTAL KNEE ARTHROPLASTY. LOOSENING OF TIBIAL AND FEMORAL COMPONENTS. MEDDRA CODE - 10021539, DEVICE RELATED: DEFINITELY RELATED, PROCEDURE RELATED: POSSIBLY RELATED, DATE OF EVENT: 15 JUL 2024, DATE OF IMPLANT: (B)(6) 2013, DATE OF REVISION: (B)(6) 2024, DEVICE LOCATION: LEFT. TREATMENT/IMPACT: REQUIRES IN PATIENT HOSPITALIZATION, RESULTS IN A MEDICAL OR SURGICAL INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE OR FUNCTION, MEDICAL INTERVENTION/MODIFICATION, REVISION OF LEFT TOTAL KNEE ARTHROPLASTY, COMPONENTS REMOVED: FEMORAL COMPONENT, TIBIAL BASE, TIBIAL INSERT, AND PATELLAR COMPONENT. (FOR PREVIOUSLY RESURFACED PATELLA)

  Patient problems: Insufficient Information

  MAUDE report 23295071 ↗
• InjuryAug 21, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO FALL. SYNOVECTOMY, TIBIA REVISION & POLY EXCHANGE WAS PERFORMED. THERE WERE NO DELAYS AND NO ADVERSE EFFECTS. PRODUCT STATED TO BE LOOSE: TIBIA LOOSENING INTERFACE: CEMENT/IMPLANT, CEMENT MANUFACTURER: UNKNOWN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall

  MAUDE report 22859691 ↗
• InjuryMar 4, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF TIBIA AT CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURE WAS DEPUY. THERE WAS ALSO INFECTION IN KNEE. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 21514432 ↗
• InjuryNov 12, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  (B)(6) 2017: PATIENT UNDERWENT A RIGHT TKA FOR DJD. DEPUY COMPONENTS PLACED WITH THE PATELLA RESURFACED. DEPUY CEMENT X2 WAS USED. NO COMPLICATIONS WERE NOTED. (B)(6) 2018: PATIENT EXPERIENCED A "LOUD POP" AND PAIN. PATIENT UNDERWENT A REVISION FOR ASEPTIC LOOSENING. THE TIBIAL TRAY WAS FOUND TO BE GROSSLY LOOSE AND WAS DEBONDED FROM THE CEMENT MANTLE. THE TIBIAL INSERT AND FEMORAL COMPONENT WAS ALSO REMOVED WITH NO ALLEGATIONS. THE PATELLA WASN'T REVISED AND COMPETITOR COMPONENTS AND CEMENT WERE PLACED IN A REVISION. DOI: (B)(6) 2017; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 20664113 ↗
• InjuryNov 11, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT RECEIVED AN ATTUNE PRIMARY LEFT TOTAL KNEE ARTHROPLASTY TO ADDRESS DEGENERATIVE ARTHRITIS ON (B)(6) 2016. DEPUY BONE CEMENT WAS USED. AS PART OF THE TREATMENT, PATIENT ALSO RECEIVED AUTOLOGOUS PLATELET RICH PLASMA WHICH WAS APPLIED TO THE DEEP PORTIONS OF THE PATIENT'S INCISION DURING WOUND CLOSURE TO SUPPORT WOUND HEALING. THE PATIENT HAD NO COMPLICATIONS. PATIENT'S LEFT TOTAL KNEE WAS REVISED ON (B)(6) 2024, TO ADDRESS ASEPTIC IMPLANT LOOSENING OF THE TIBIAL BASEPLATE WITH COMPLETE DEBONDING (CEMENT TO IMPLANT INTERFACE) AND CHRONIC PATELLAR TENDON RUPTURE. FEMUR, TIBIAL BASEPLATE, AND INSERT WERE EXPLANTED. PATELLA COMPONENT WAS WELL-FIXED AND RETAINED. PATELLA TENDON WAS REINFORCED WITH A TUBULARIZED MARLEX MESH BUNDLE. THERE WERE NO COMPLICATIONS. COMPETITOR REVISION FEMUR AND TIBIAL COMPONENTS WERE IMPLANTED. DOI: (B)(6) 2016; DOR: (B)(6) 2024; LEFT KNE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20658814 ↗
• InjuryNov 6, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  DOI: (B)(6) 2018: 60-YEAR-OLD FEMALE PATIENT RECEIVED AN ATTUNE RIGHT KNEE TKA TO TREAT DJD. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOR: (B)(6) 2022: 65-YEAR-OLD FEMALE PATIENT RECEIVED A TOTAL RIGHT KNEE REVISION TO TREAT PAIN, GROSS INSTABILITY, AND LOOSENING OF THE TIBIAL TRAY. UPON ENTERING THE JOINT, THE SURGEON DEBRIDED EXTENSIVE SCAR TISSUE. THE TIBIAL TRAY WAS LOOSE AT AN UNKNOWN INTERFACE. THE FEMORAL COMPONENT WAS WELL-FIXED BUT REVISED DUE TO FEMORAL BONE LOSS. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT AND PATELLA. THE PATIENT RECEIVED AND UNKNOWN REVISION CONSTRUCT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2018. DOR: (B)(6) 2022. RIGHT KNEE.

  Patient problems: Adhesion(s); Joint Laxity; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 20621946 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY OF KNEE. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 19941180 ↗
• InjuryApr 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS BEING REVISED DUE TO INFECTION. ALL HARDWARE FROM A PRIMARY TOTAL KNEE WAS REMOVED AND A CEMENT SPACER WAS PLACED IN THE PATIENT. DOR: (B)(6) 2024 AFFECTED SIDE: LEFT KNEE

  Patient problems: Unspecified Infection

  MAUDE report 19192052 ↗
• InjuryMar 25, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  VOLUNTARY REPORT RECEIVED: THE PATIENT'S WIFE REPORTED THAT THE PATIENT HAD RIGHT KNEE REPLACED IN 2017. THE SURGICAL PROCEDURE APPEARED TO HAVE GONE WELL FOR ABOUT THE FIRST THREE MONTHS. THEN PATIENT BEGAN OR CONTINUED TO HAVE PAIN IN HIS RIGHT KNEE. PATIENT FOLLOWED UP WITH THE SURGEON WHO DID X-RAYS AND FOUND NO ISSUES. THE PROBLEMS CONTINUED AND PATIENT AGAIN WENT IN FOR ONE-YEAR POST OP APPOINTMENT. PATIENT WAS TOLD THAT SOMETIMES KNEE JOINTS DON'T FIT AS WELL FOR SOME PATIENTS. THE PAIN CONTINUED AND BECAME SO INTENSE AT THE BEGINNING OF 2023 THAT PATIENT SOUGHT ASSISTANCE FROM A DIFFERENT SURGICAL GROUP. THE X-RAYS IMMEDIATELY SHOWED THAT THE ORTHOPEDIC JOINT WAS MOVING IN PATIENT'S LEG. PATIENT WOULD HAVE TO HAVE A REVISION SURGERY FOR CORRECTION. PATIENT HAD THIS SURGERY ON (B)(6) 2023. IT WAS TOLD BY THE SURGEON THAT THE ORIGINAL REPLACEMENT FAILED BEFORE PATIENT¿S KNEE WAS EVEN CLOSED UP AS NONE OF THE CEMENT ADHERED TO ANY PART OF THE ARTIFICIAL JOINT. THE NEW SURGEON HAD TO DO EXTENSIVE DEBRIDEMENT OF THE BONES AS THE CEMENT WAS IN THE BONES. PATIENT TOLD BOTH PARTS OF THE ORIGINAL REPLACEMENT JUST POPPED OUT.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 18968506 ↗
• InjuryMar 18, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO PAINFUL KNEE. THERE WAS TIBIAL LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. DOI: (B)(6) 2017. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 18920553 ↗
• InjuryFeb 29, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  NO SURGICAL DELAY.

  Patient problems: Fall; Joint Laxity; Unspecified Tissue Injury

  MAUDE report 18807228 ↗
• InjuryJan 29, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED DUE TO INCREASING PAIN AND INSTABILITY AND PATELLA AND TIBIAL REVISION WAS PERFORMED. THE TIBIA WAS LOOSE AT THE CEMENT/IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2015. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 18596745 ↗
• InjuryJan 24, 2024Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  ADDITIONAL INFORMATION WAS RECEIVED: 1. CAN YOU CONFIRM THE PRIMARY SURGERY DATE OR THE ORIGINAL IMPLANTATION DATE? - 2015 ORIGINAL SURGERY. 2. WAS THERE ANY ADVERSE CONSEQUENCE TO THE PATIENT RELEVANT TO THIS EVENT? IF YES, PLEASE KINDLY PROVIDE DETAILS. - NO. 3. IT WAS INDICATED THAT THERE WAS LOOSENING. ON WHAT INTERFACE DID THE LOOSENING OCCURRED? -IMPLANT/CEMENT. 4. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? - NO. 5. WAS THERE ANY ALLEGATION AGAINST THE TIBIAL INSERT? - NO.

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

  MAUDE report 18570475 ↗
• InjuryNov 22, 2023Loss of or Failure to Bond; Use of Device Problem; Loss of or Failure to Bond; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT HAD A LEFT TOTAL ATTUNE KNEE WITH A LOOSE TIBIAL TRAY. THE KNEE WAS DONE BY A PRIMARY SURGEON. THE TIBIAL TRAY HAD FALLEN INTO THE VARUS, AND AFTER TAPPING ON THE FEMORAL COMPONENT, IT WAS DISCOVERED THAT IT WAS LOOSE TOO. THESE COMPONENTS WERE REVISED. THE PATELLA WAS WELL FIXED AND RETAINED. SURGICAL DELAY WAS UNKNOWN. THE LOOSENING INTERFACE WAS UNKNOWN AND CEMENT MANUFACTURER WAS UNKNOWN. DOI: (B)(6) 2017. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18192364 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR BAKER'S CYST. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2013. DATE OF EVENT: (B)(6) 2013 (LEFT KNEE). TREATMENT: US GUIDED ASPIRATION AND STEROID INJECTION.

  Patient problems: Cyst(s)

  MAUDE report 18141166 ↗
• InjuryOct 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A RIGHT TOTAL ATTUNE KNEE THAT WAS INFECTED MOST LIKELY DUE TO A TOE INFECTION THAT THE PATIENT HAD ON THE SAME LEG. ALL COMPONENTS WERE REMOVED AND TEMPORARY SPACERS IMPLANTED UNTIL THE INFECTION WAS GONE. DOI: (B)(6) 2017; DOR: (B)(6) 2023; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17885657 ↗
• InjuryAug 30, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING OF THE TIBIA AT THE CEMENT TO IMPLANT INTERFACE. THE CEMENT MANUFACTURER WAS COMPETITOR. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2016, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 17649436 ↗
• InjuryMar 7, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS HAVING INCREASING PAIN AND DECREASED RANGE OF MOTION. THE TIBIA WAS REVISED. THIS IS THE ORIGINAL ATTUNE TIBIAL TRAY, KNOWN TO LOOSEN. LOOSENING OF THE TIBIA WAS REPORTED AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. DOI: ON (B)(6) 2016, DOR: ON (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 16494974 ↗
• InjuryFeb 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ATTUNE TIBIA REVISED. DOI: UNKNOWN. DOR: (B)(6) 2023. LEFT KNEE.

  Patient problems: Pain

  MAUDE report 16361873 ↗
• InjuryNov 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 15840059 ↗
• InjuryNov 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A SIGNIFICANT FLEXION CONTRACTURE, SURGEON NEED TO REVISE TO ALLOW ROM. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Contracture; Loss of Range of Motion

  MAUDE report 15788289 ↗
• 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 15751288 ↗
• InjuryOct 30, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION COMPLETED DUE TO PAIN/STIFFNESS AND LOOSENING OF THE FEMORAL COMPONENT. SCAR TISSUE WAS REMOVED. ALL COMPONENTS WERE REMOVED. ATTUNE REVISION WAS IMPLANTED. THE PATELLA WAS REMOVED SO WE COULD GAIN BETTER ACCESS TO THE JOINT SPACE. THIS WAS WELL FIXED. THE FEMORAL COMPONENT WAS VERY LOOSE AND 'FELL OFF' WHEN WE WERE TRYING TO REMOVE THE INSERT. CEMENT WAS WELL FIXED AT THE IMPLANT/CEMENT INTERFACE, BUT NOT AT THE CEMENT/BONE INTERFACE. THE TIBIA WAS WELL FIXED. THE BONE/CEMENT INTERFACE WAS WELL FIXED COMPARED TO THE CEMENT/IMPLANT INTERFACE. THE SURGEON SAID THE PRIMARY SURGERY WAS DONE IN 2017 WHERE THE PATIENT HAD A BILATERAL KNEE REPLACEMENT. AS THE PATIENT NOTES WEREN'T COMPLETE I HAD TO DO MY BEST TO READ THE LOT NUMBERS OF THE EXPLANTED COMPONENTS. THE LEFT SIDE WAS REVISED (I THINK) ON (B)(6) 2021 FOR PAIN AND STIFFNESS. I'M UNSURE ABOUT LOOSENING. I DON'T KNOW THE PC NUMBER FOR THIS REVISION.

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

  MAUDE report 15697575 ↗
• InjuryAug 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS FED ION CONTRACTURE AND FIBROTIC TISSUE. DOI: (B)(6) 2015, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s); Joint Contracture

  MAUDE report 15303077 ↗
• InjuryJul 29, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  (B)(4) MEDICAL RECORDS AD 14 JUL 2022, WERE REVIEWED BY CLINICIAN. ON (B)(6) 2019, THE PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY TO ADDRESS LEFT KNEE SEVERE DEGENERATIVE JOINT DISEASE. DEPUY COMPONENTS, INCLUDING DEPUY PATELLA AND DEPUY CEMENT X2 WERE UTILIZED DURING THIS PROCEDURE. ON (B)(6) 2021, THE PATIENT HAD A LEFT TOTAL KNEE REVISION TO ADDRESS MECHANICAL COMPLICATIONS. FINDINGS ON THE MEDICAL RECORDS NOTE THAT THE TIBIAL COMPONENT WAS LOOSE, WITH NO INTERFACE PROVIDED. COMPETITOR COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE. DOI: (B)(6) 2019, DOR: (B)(6) 2021, (LEFT KNEE).

  Patient problems: Insufficient Information; Pain; Swelling/ Edema

  MAUDE report 15130267 ↗