ATTUNE 1506-10-006Recalls & reported problems

Summary

The FDA's MAUDE database contains 255 adverse event reports that list this exact device (DI 10603295042600), received between Jun 29, 2017 and Aug 10, 2026 — classified as 1 death, 253 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (196 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 255 reports, in the reporter's own words as published by the FDA.

• InjuryAug 10, 2026Loss of or Failure to Bond

  It was reported that the patient has a loose tibial component. Doctor removed the tibial component and replaced with a revision tibia, stem and sleeve. Also replaced with the appropriate size poly for stability. No cement on the tibial component when it was explanted. It was stated that tibial component was loose. Loosening interface was marked as Cement to Implant.DOI: (b)(6) 2017.DOR: (b)(6) 2026.Affected side: Right.

  Patient problems: Joint Laxity

  MAUDE report 50193843 ↗
• InjuryMay 4, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT SURGEON REVISED THE ATTUNE PS RP KNEE DUE TO TIBIAL BASE LOSING. A STEM AND SLEEVE OF THE ATTUNE REVISION WAS IMPLANTED IN BOTH THE FEMUR AND TIBIA. NO DELAYS OR COMPLICATIONS OCCURRED. ACTIVITY LEVEL - YES. DOI: UNKNOWN DOR: (B)(6), 2026 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 25074152 ↗
• InjuryDec 1, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT HAD KNEE SURGERY AT SURGERY CENTER BY DR. ON (B)(6) 2017. UNFORTUNATELY, THE PATIENT¿S TIBIAL COMPONENT BECAME LOOSE, THE DR. HAD TO REVISE THE KNEE BECAUSE THE PATIENT WAS SUFFERING FROM KNEE PAIN AND THE DR. FELT IT WAS DUE TO THE LOSS OF COMPONENTS. REVISION COMPONENTS WERE PUT IN AND THE KNEE WAS FOUND TO BE STABLE. ACTIVITY LEVEL - YES. DOI: (B)(6) 2017. DOR: UNKNOWN. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 23682327 ↗
• InjuryMar 17, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY. THERE WAS NO SPECIFIC ALLEGATION AGAINST THE ATTUNE PS RP INSRT SZ7 5MM.

  Patient problems: Discomfort; Pain

  MAUDE report 21619941 ↗
• InjuryMar 13, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE SURGEON PERFORMED A REVISION OF AN ATTUNE CRRP CONSTRUCT FOR LOOSENING OF TIBIAL AND FEMORAL COMPONENTS. TIBIA WAS LOOSE AT THE IMPLANT/CEMENT INTERFACE. FEMUR WAS LOOSE AS THE CEMENT/BONE INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 21593106 ↗
• InjuryJan 31, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF TIBIA AT UNKNOWN INTERFACE. THIS WAS A PRE S+ TIBIA. THE POLY WAS ALSO CHANGED AS WELL. CEMENT MANUFACTURER WAS UNKNOWN. DOI: UNKNOWN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21285107 ↗
• InjuryNov 19, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAINFUL KNEE. THERE WAS LOOSENING OF THE TIBIA AT THE CEMENT/IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2017. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 20727201 ↗
• InjuryJun 19, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  LITIGATION COMPLAINT RECEIVED AD 5 JUN 2024. ON (B)(6) 2017, THE PATIENT HAD A RIGHT KNEE ARTHROPLASTY TO ADDRESS DEGENERATIVE ARTHRITIS. DEPUY COMPONENTS WERE PLACED DURING THIS PROCEDURE, INCLUDING DEPUY CEMENT AND PATELLA. ON (B)(6) 2023, THE PATIENT HAD A RIGHT TOTAL KNEE REVISION TO ADDRESS ASEPTIC LOOSENING OF THE RIGHT TOTAL KNEE AND FEMORAL OSTEOLYSIS. PRIOR TO SURGERY, THE PATIENT WAS REPORTED TO HAVE HAD PAIN, DECREASE RANGE OF MOTION, STIFFNESS, FIBROSIS, DECLINING FUNCTION. DURING THE PROCEDURE, THE SURGEON REPORTED FINDING OSTEOLYSIS OF THE FEMUR AND NO CEMENT ADHERED TO BACK OF THE TIBIAL TRAY. (LOOSENING) OSTEOPHYTES WERE REMOVED FROM THE PATELLA. COMPETITOR COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE, INCLUDING COMPETITOR CEMENT. UPDATE AD 5 JUN2024: UPDATE EVENT DESCRIPTION: ON (B)(6) 2017, THE PATIENT HAD A RIGHT KNEE ARTHROPLASTY TO ADDRESS DEGENERATIVE ARTHRITIS. DEPUY COMPONENTS WERE PLACED DURING THIS PROCEDURE, INCLUDING DEPUY CEMENT AND PATELLA. (B)(6) 2022 MEDICAL RECORDS NOTE RIGHT KNEE PAIN AND DYSFUNCTION AFTER TKA, AS WELL AS LEFT KNEE PAIN (NO IMPLANT) RIGHT KNEE PAIN, SWELLING, DECREASE RANGE OF MOTION, STIFFNESS. PATIENT HAD A PREVIOUS INJECTION

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

  MAUDE report 19567939 ↗
• InjuryMay 23, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO LOOSE TIBIA AT IMPLANT FROM CEMENT MANTEL. SURGEON REVISED THE FEMUR, TIBIA, INSERT. THERE WAS NO SURGICAL DELAY AND NO BROKEN INSTRUMENTS. DOI: UNKNOWN. DOR: (B)(6), 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19380926 ↗
• InjuryMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 19312475 ↗
• InjuryOct 16, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THERE WAS AN DEPUY ATTUNE KNEE REPLACEMENT THAT EXPIRED PREMATURE. DOI: (B)(6) 2018 DOR: UNKNOWN AFFECTED SIDE : LEFT KNEE. ADDITIONAL EVENT INFORMATION PROVIDED BY PATIENT STATING THAT PATIENT HAD A LEFT TOTAL KNEE DONE IN (B)(6) 2018 AND HAS BEEN EXPERIENCING PAIN. THE PATIENT HAD RADIOGRAPHS DONE THAT ARE REPORTED TO SHOW THAT THERE IS LOOSENING OF THE "TOP AND BOTTOM" (TIBIAL TRAY AND FEMORAL COMPONENT). THE PATIENT IS SCHEDULING A REVISION AND WOULD BE INTERESTED IN COMPENSATION AS HE HAD HEARD HIS KNEE WAS IN A RECALL. PATIENT PROVIDED PART/LOT NUMBERS FOR THE COMPONENTS, INCLUDING THE CEMENT.

  Patient problems: Pain

  MAUDE report 17939138 ↗
• InjurySep 5, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO INFECTION AND TIBIAL LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. IRRIGATION AND DEBRIDEMENT WITH CONSTRAINED COMPONENTS AS A TEMPORARY SPACER. DOI: (B)(6) 2018. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17683499 ↗
• InjuryJun 9, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  LITIGATION COMPLAINT RECEIVED AD (B)(6) 2023.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Fatigue; Joint Laxity; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 17097443 ↗
• InjuryJun 9, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2022, PATIENT HAS RIGHT KNEE PAIN, GAIT INSTABILITY, JOINT SWELLING, LIMPING, WEAKNESS, AND KNEE GIVING AWAY. SHE WAS TREATED WITH PHYSICAL THERAPY, NSAIDS, ALEVE AND DRY NEEDLING. IT WAS NOTED THE PATIENT HAD RECEIVED LUMBAR EPIDURAL INJECTIONS DUE TO LUMBAR SPONDYLOLISTHESIS, DISC DEGENERATION, AND IDIOPATHIC SCOLLOSIS LUMBAR REGION.

  Patient problems: Ambulation or Postural Difficulties; Fatigue; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 17096975 ↗
• InjuryJan 31, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT HAD PRIMARY KNEE REPLACEMENT ON (B)(6) 2018. KNEE PERFORMING WELL INITIALLY BUT PATIENT STARTED EXPERIENCING PAIN IN LAST 6 MONTHS. X-RAYS & BONE SCAN SHOWED TIBIAL LOOSENING. TIBIA & INSERT REMOVED ON (B)(6) 2023 AND REPLACED WITH REVISION TIBIA WITH SLEEVE, STEM & NEW INSERT PLUS PATELLA RESURFACING. PRIMARY TIBIAL IMPLANT WAS OBVIOUSLY LOOSE ON EXAMINING KNEE ONCE JOINT OPENED. CAME OUT EASILY. CEMENT ADHERED TO BONE BUT NOT IMPLANT. INSERT SHOWED SOME SCRATCHING/PITTING ON ARTICULATION SURFACE. PATIENT REQUIRED REVISION SURGERY FOR TIBIAL LOOSENING AT THE CEMENT TO IMPLANT INTERFACE.

  Patient problems: Pain

  MAUDE report 16273118 ↗
• InjuryJan 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD PAIN. HIS TIBIA WAS POSSIBLY LOOSE BUT INCONCLUSIVE. SURGEON CONDUCTED A FULL EXPLANT AND REVISION. THE LOOSENING INTERFACE IS AT THE CEMENT TO IMPLANT INTERFACE. DOI: (B)(6) 2018. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 16271025 ↗
• InjuryDec 8, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  ¿VOLUNTARY REPORT RECEIVED (MW5113219) PATIENT STATED: I HAD ARTHRITIS AND SAW AN ORTHOPEDIC SURGEON. HE IMPLANTED AN ATTUNE L KNEE PROTHESIS. FROM DAY 1 I HAD PROBLEMS. SEVERE PAIN; SWELLING AND EVEN THE PHYSICAL THERAPIST RELAYED SYMPTOMS UNUSUAL. I FINALLY HAD CT DONE AND IT SHOWED DEBONDING OF PROTHESIS AND THE ORIGINAL SURGEON RELAYED HE DOES NOT DO REVISIONS I FINALLY FOUND AN EXCELLENT ORTHO DOCTOR W/ (B)(6), AND HE SAW RESULTS OF CT AND HE REPLACED THE ATTUNE DEVICE W/ A STRYKER DEVICE. BUT IN INTERIM OF FOLLOW UP FROM 1ST SURGERY IMPLANT OF ATTUNE DEVICE, I HAD ADDITIONAL SURGERY FOR LEFT KNEE NEUROMA; THEN STILL HAD ISSUES AND SWELLING. RECENTLY I HAD THE PERONEAL NERVE LEFT KNEE DECOMPRESSED BY SAME SURGEON WHO DID THE REVISION: DR. (B)(6). THE ORIGINAL SURGEON AND HIS COLLEAGUE HE SENT ME TO TREAT ME AS A HYSTERICAL FEMALE. PS I AM AN RN IN MY 60'S SO I KNOW MY BODY VERY WELL, AND I KNEW THE SEVERE PAIN I WAS FEELING WAS NOT NORMAL. EVEN DR. (B)(6), THE ORIGINAL SURGEON, HIS OWN THERAPIST HAD ADMITTED TO MET THE PAIN AND SYMPTOMS I WAS HAVING WERE VERY ABNORMAL."

  Patient problems: Nerve Damage; Pain; Swelling/ Edema

  MAUDE report 15940815 ↗
• InjuryDec 2, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT PRESENTED WITH PAIN IN KNEE. X RAY SHOWED A LOOSENING AROUND TIBIA AT CEMENT TO IMPLANT INTERFACE. TIBIA POPPED RIGHT OUT. TIBIA WAS REVISED. THERE WAS NO SURGICAL DELAY. DOI: ON (B)(6) 2015. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 15902715 ↗
• InjuryNov 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DR (B)(6) REVISED AN ATTUNE PRIMARY TODAY FOR INSTABILITY. HE DID NOT DO THE PRIMARY CASE AND REVISED WITH ZIMMER SO NONE OF OUR PRODUCTS WERE USED. DR (B)(6) STATED THE INDEX SURGERY LIKELY TOOK TOO MUCH OFF THE DISTAL FEMUR WHICH LED TO TIGHT FLEXION AND LOOSE EXTENSION GAPS. HE STATED IT WAS TECHNIQUE RELATED NOT IMPLANT RELATED. THE PRIMARY PROCEDURE WAS DONE BY DR (B)(6) ON (B)(6) 2020 BUT UNKNOWN HOSPITAL. I DO NOT HAVE THE LOT NUMBERS AS WE COULD NOT READ THEM, WILL TRY TO GET DETAILS FROM CUSTOMER SERVICE.

  Patient problems: Joint Laxity

  MAUDE report 15874543 ↗
• InjuryNov 14, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION COMPLETED DUE TO LOOSENING OF TIBIA COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. IN ADDITION, LYSIS HAD FORMED AROUND THE FEMORAL COMPONENT AND THE FEMORAL COMPONENT HAD TO BE REVISED AS WELL. ATTUNE RP PS TKA REVISED. THE SURGEONS BELIEVED THIS TO BE A DIRECT RESULT OF THE IMPLANT DESIGN. THE PATELLA WAS NOT REVISED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2017. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 15794309 ↗
• InjuryOct 13, 2022Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  PATIENT WAS REVISED DUE TO ASEPTIC TIBIAL AND FEMORAL LOOSENING. TIBIAL TRAY HAD ALSO FALLEN INTO VARUS. FEMORAL COMPONENT LOOSENED AT THE CEMENT/BONE INTERFACE. TIBIAL COMPONENT LOOSENED AT THE CEMENT/IMPLANT INTERFACE. TIBIAL TRAY¿S UNDERSIDE WAS COMPLETELY CLEAN OF CEMENT WHEN REMOVED. CEMENT MANUFACTURER WAS UNKNOWN. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2014; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 15594534 ↗
• InjuryJul 1, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  ATTUNE MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS RECEIVED THE PATIENT WAS REVISED TO ADDRESS LOOSE CEMENTED ATTUNE TIBIAL BASEPLATE RESULTING TO PAIN. OPERATIVE NOTE REPORTED PATIENT HAD A LOOSE CEMENTED ATTUNE TIBIA FROM THE PRIMARY LINEAGE AFTER RECONSTRUCTION. THERE WAS NO CEMENT ON THE TIBIAL BASEPLATE AND COMPLETE CEMENT MATLE WAS IDENTIFY IN THE TIBIAL BONE. THERE WAS EXTENSIVE AMOUNT OF CEMENT IN THE TIBIA. DOI: (B)(6) 2012;. DOR: (B)(6) 2022;. RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 14885445 ↗
• InjuryJul 1, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  (B)(4) MEDICAL RECORDS AD (B)(6) 2022. PDF WERE REVIEWED BY CLINICIAN. ON (B)(6) 2016, THE PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY. DEPUY COMPONENTS, INCLUDING DEPUY PATELLA AND DEPUY CEMENT X2 WERE USED DURING THIS PROCEDURE. ON (B)(6) 2021, THE PATIENT HAD A REVISION ALL COMPONENTS TO ADDRESS FAILED LEFT TOTAL KNEE REPLACEMENT DUE TO ASEPTIC LOOSENING OF THE TIBIAL COMPONENT. DURING THE PROCEDURE THE SURGEON REPORTED THAT THE FEMORAL COMPONENT WAS WELL FIXED, THE TIBIAL TRAY WAS GROSSLY LOOSE WITH INTACT CEMENT MANTLE. THE SURGEON ALSO OBSERVED SOME BONE LOSS AND CYSTIC CHANGES ALONG THE FEMUR. THERE WAS POLYWEAR AND SYNOVIAL REACTION NOTED. COMPETITOR PRODUCTS WERE IMPLANTED DURING THIS PROCEDURE. DOI: (B)(6) 2016. DOR: (B)(6) 2021. LEFT KNEE.

  Patient problems: Synovitis

  MAUDE report 14884830 ↗
• InjuryJun 27, 2022Loss of or Failure to Bond; Break; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON 2016, AGAINST A DEPUY ATTUNE TOTAL KNEE REPLACEMENT PROCEDURE. THE SURGERY WAS NOT COMPLETED PROPERLY AND PAIN AND SWELLING CONTINUED FOR OVER 6 YEARS. ON THIS YEAR, THE SURGEON OPERATED AND FOUND THE IMPLANT WAS LOOSE AND HAD TO DO A TOTAL KNEE REVISION TO CHANGE IT. REASON FOR REVISION: PAIN, SWELLING, EXTENSIVE METALLOSIS, LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE (UNKNOWN CEMENT). DOI: (B)(6) 2016. DOR: (B)(6) 2022. LEFT KNEE.

  Patient problems: Foreign Body Reaction; Pain; Swelling/ Edema

  MAUDE report 14828953 ↗
• InjuryMay 13, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE ATTUNE TIBIAL TRAY WAS GROSSLY LOOSE AT THE CEMENT TO IMPLANT INTERFACE AND WAS REMOVED WITH AN RP INSERT. ZERO CEMENT WAS ON THE TIBIAL TRAY AND WAS TAKEN OUT BY HAND. ATTUNE REVISION RP TRAY AND SLEEVE WERE IMPLANTED. DEPUY CEMENTS WERE USED. NO ADDITIONAL INFORMATION WILL BE PROVIDED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2013; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 14393719 ↗