ATTUNE 1506-10-003Recalls & reported problems

Summary

The FDA's MAUDE database contains 185 adverse event reports that list this exact device (DI 10603295042570), received between Jul 25, 2017 and Feb 11, 2026 — classified as 183 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (148 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 185 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO GLOBAL INSTABILITY. DOI: (B)(6) 2018. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24316086 ↗
• InjuryOct 30, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING PRIMARY IMPLANTS. THERE WAS LOOSENING OF FEMUR, TIBIA AT CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURE WAS UNKNOWN. ITEMS WERE UNAVAILABLE FOR RETURN. THERE WAS NO DELAY OR COMPLAINTS. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23427951 ↗
• InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING KNEE PAIN AND INSTABILITY. DOI: (B)(6) 2018, DOR: (B)(6) 2025 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 22676742 ↗
• InjuryFeb 26, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT DEVELOPED PAIN AND SHOWED SIGNS OF LOOSENING. RADIOGRAPHS SHOWED LOOSE TIBIAL COMPONENT. AT CEMENT TO IMPLANT INTERFACE. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 21472714 ↗
• InjuryJan 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO A STIFF KNEE WITH LOW ROM AND THE IMPLANTS WERE WELL FIXED. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 21210132 ↗
• InjuryJan 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Pain

  MAUDE report 21173716 ↗
• InjuryOct 8, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL RIGHT KNEE REVISION FOR TIBIAL ASEPTIC LOOSENING. THERE WAS INTERFERENCE WITH THE IMPLANT/CEMENT SURFACE. PATIENT EXPERIENCED PAIN. ON (B)(6) 2024, PATIENT UNDERWENT REVISION SURGERY. DEVICE WAS EXPLANTED.

  Patient problems: Pain

  MAUDE report 20397135 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF ATTUNE PRIMARY IMPLANTS. REVISION DUE TO PATIENT PAIN AND CYST FORMATION BEHIND THE FEMORAL IMPLANT. ORIGINAL SURGERY DATE UNKNOWN.

  Patient problems: Cyst(s); Pain

  MAUDE report 20279973 ↗
• InjuryJun 25, 2024Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO THE RIGHT TOTAL ATTUNE KNEE WITH A TIBIAL TRAY THAT HAD FALLEN INTO SEVERE VARUS. THE TIBIAL TRAY WAS REVISED, AND THE FEMUR AND PATELLA WERE WELL FIXED AND RETAINED. THE TRAY DID NOT HAVE ANY CEMENT STUCK TO IT'S BACKSIDE. DURING BROACHING OF THE TIBIA, THE TIBIAL BROACH HANDLE BROKE. ALL PIECES WERE FOUND. DOI: (B)(6) 2017. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19604231 ↗
• MalfunctionMar 22, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  STUDY NO: (B)(6) CLINICAL ADVERSE EVENT RECEIVED FOR PROSTHESIS LOOSENING. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: ON (B)(6) 2015, DATE OF EVENT: UNK JAN 2023, (LEFT KNEE). TREATMENT: DIAGNOSTIC INTERVENTION AND OBSERVATION.

  Patient problems: Insufficient Information

  MAUDE report 18959167 ↗
• InjuryMar 20, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION FOR DESCHELLEMENT PTG KNEE RIGHT DUE TO LOOSENING OF FEMUR-TIBIA. THERE WAS NO DELAY.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 18940301 ↗
• InjuryJan 16, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO TIBIAL LOOSENING. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: (B)(6), 2016. DOR: (B)(6), 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18519837 ↗
• InjuryDec 8, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO THE LOOSENING OF TIBIA FIRST GENERATION ATTUNE RP AT CEMENT TO IMPLANT INTERFACE . PATIENT WAS A BMI OVER 40 AT THE ORIGINAL SURGERY DATE. DOI: UNKNOWN AND DOR: UNKNOWN AFFECTED SIDE : LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18291610 ↗
• InjuryNov 9, 2023Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  ON 10/12/2023 MEDICAL RECORDS NOTE THE PATIENT HAD A LEFT KNEE IMPLANTED (B)(6) /2016. THREE MONTHS AGO, THE PATIENT DEVELOPED INSIDIOUS ONSET OF PAIN AND VARUS DEFORMITY. LOOSENING OF LEFT TIBIAL TRAY AND PAIN WERE NOTED. ADDITIONAL INFORMATION RECEIVED: A. WAS THERE A SURGICAL DELAY BECAUSE OF THIS EVENT? NO. B. WHAT IS THE LOOSENING INTERFACE? CEMENT & IMPLANT AS WELL AS CEMENT AND BONE.

  Patient problems: Insufficient Information; Pain

  MAUDE report 18101360 ↗
• InjuryAug 18, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE SURGEON REMOVED SIZE 4 TIBIA DUE TO LOOSENING AND REPLACED IT WITH A REVISION OF TRAY AND SLEEVE. DOI: UNKNOWN, DOR: UNKNOWN, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 17571502 ↗
• InjuryJul 27, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  THIS MDR REPORT IS RELATED TO MDR REPORT NUMBERS 3011632150-2022-00046 AND 3011632150-2022-00047. THE PATIENT WAS TREATED AS PART OF THE MIMICS 3D USA POST-MARKET OBSERVATIONAL STUDY ON (B)(6) 2021. THE SUBJECT WAS IMPLANTED WITH THREE BIOMIMICS 3D STENTS (A 7.0 X 150MM (THIS REPORT), AND TWO 7.0 X 125 MM STENTS) TO TREAT A DENOVO LESION OF THE SFA OSTIAL TO SFA DISTAL THIRD ARTERY IN THE LEFT LEG. A CONTRALATERAL APPROACH WAS USED AND THE LESION WAS PREPARED USING PRE-DILATION WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND ATHERECTOMY. THE TREATED SEGMENT WAS POST-DILATED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). ON (B)(6) 2022, AN EVENT OF OCCLUSION WAS REPORTED. IT WAS REPORTED AS "NOT RELATED" TO THE DEVICE OR PROCEDURE BUT WAS DUE TO A WORSENING PRE-EXISTING CONDITION. IT WAS ALSO REPORTED AS TARGET LESION RELATED. THE PATIENT OUTCOME WAS REPORTED AS RESOLVED/RECOVERED. THE FIRST INTERVENTION WAS A LASER ATHERECTOMY AND ATTEMPTED ATHERECTOMY/CROSSING OF THE LESION IN THE SFA PROXIMAL THIRD TO PROXIMAL POPLITEAL SEGMENT THAT TOOK PLACE ON 24-JAN-22. A SUBSEQUENT INTERVENTION ON 24-FEB-22 INVOLVED AN ADDITIONAL BM3D STENT PLACEMENT, PTA/STANDARD BALLOON ANGIOPLASTY

  Patient problems: Adhesion(s); Deformity/ Disfigurement; Hypersensitivity/Allergic reaction; Muscular Rigidity; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 17404444 ↗
• InjuryJul 12, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL TRAY AT THE CEMENT AND IMPLANT INTERFACE AND GLOBAL INSTABILITY. CEMENT MANUFACTURER WAS UNKNOWN. THE SURGEON EXPLANTED THE TRAY, REVISING IT WITH A REVISION FB CONSTRUCT. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2023; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17309864 ↗
• InjuryMar 14, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL TRAY AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 16539218 ↗
• InjuryJan 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON REMOVED ALL COMPONENTS AND REVISED TO AN ANTIBIOTIC SPACER BECAUSE THE KNEE WAS INFECTED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2017. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16266443 ↗
• InjuryJan 13, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF TIBIA AT CEMENT TO IMPLANT INTERFACE. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2017. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 16157232 ↗
• MalfunctionDec 8, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  FOREIGN MATTER. IT WAS REPORTED THAT DURING THE SURGERY, OPENED THE PACKAGE, FOUND FOREIGN MATTER AS THE PHOTO SHOWS. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15940075 ↗
• InjuryAug 16, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  A REVISION SURGERY WAS REQUIRED FOR A PATIENT WITH SUSPECTED ASCEPTIC TIBIAL LOOSENING OF THEIR ATTUNE TIBIAL COMPONENT. DURING SURGERY TO INSPECT, IT WAS APPARENT THAT THE TIBIAL COMPONENT WAS IN FACT LOOSE OR WHAT APPEARED TO BE DEBONDED FROM THE CEMENT. A TIBIAL REVISION WAS PERFORMED WITH AN ATTUNE TIBIAL REVISION COMPONENT PLACED. THE FEMORAL COMPONENT WAS KEPT IN PLACE. THE ORIGINAL SURGERY WAS PERFORMED (B)(6) 2017. THE CEMENT USED IN THE ORIGINAL CASE WAS 1 X 40G PACK OF GMV SMARTSET: 3105-040, LOT #8391358 DOI: (B)(6) 2017. DOR: (B)(6) 2022. UNKNOWN SIDE.

  Patient problems: Pain

  MAUDE report 15232143 ↗
• InjuryJun 10, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS TIBIAL LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. COMPETITOR BONE CEMENT WAS USED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2014. DOR: (B)(6), 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 14653987 ↗
• InjuryJun 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INSTABILITY. DOI: 2016. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 14563175 ↗
• InjuryMay 18, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  TIBIAL ASEPTIC LOOSENING AT THE CEMENT/IMPLANT INTERFACE. RIGHT TIBIA, NOT CEMENT FROM DEPUY. DOI: (B)(6) 2017; DOR: (B)(6) 2022; RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 14427200 ↗