NA 1294-35-140Recalls & reported problems

Summary

The FDA's MAUDE database contains 90 adverse event reports that list this exact device (DI 10603295025979), received between Jun 26, 2017 and Mar 6, 2026 — classified as 88 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (22 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 90 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS INJURED WHILE PLAYING PICKLEBALL, MAKING THE ORIGINAL CONSTRUCT UNSTABLE. IT WAS STATED THAT THE LOOSENING OF TIBIA/FEMUR WAS UNKNOWN. DOI: (B)(6) 2019. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24532791 ↗
• InjuryAug 11, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q2 OF 2025. DARTHMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: SIGMA FEMORAL STEM, SLEEVE, AND COMPONENT AS WELL AS THE TIBIAL SLEEVE, TIBIAL STEM, AND TIBIAL TRAY WERE REVISED FOR LOOSENING AT UNKNOWN INTERFACE. THE TRUNNION OF THE TIBIAL STEM SHOWS MINOR FRETTING. THE TIBIAL SLEEVE SHOWS MINOR CORROSION.

  Patient problems: Insufficient Information

  MAUDE report 22769547 ↗
• InjuryMay 7, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q1 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 FEMORAL AND TIBIAL LOOSENING. PAIN WAS ALSO REPORTED. AT REMOVAL THE FEMORAL COMPONENT SHOWED SPARSE CEMENT REMAINING AND EXCELLENT INTERDIGIATION WITH THE BONE. AT REMOVAL THE TIBIAL COMPONENT SHOWED MODERATE CEMENT REMAINING.

  Patient problems: Pain

  MAUDE report 21979330 ↗
• InjuryApr 23, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO POSSIBLE ASEPTIC LOOSENING. REMOVED ALL IMPLANTS AND CONVERTED TO ATTUNE REVISION KNEE IMPLANTS. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21892752 ↗
• InjuryNov 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT THE PATIENT HAD TIBIA/PATELLA/POLY REVISION, DUE TO PAIN. CEMENT MANTLE OF TIBIA DIDN'T APPEAR NORMAL ON X-RAY. PATELLA HAD DELAMINATED. MBT REVISION TIBIA WITH 13X90 STEM WAS PUT IN WITH A 5X12.5 REP CVD POLY AND A 38 PATELLA. DOI: (B)(6) 2016. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 20774952 ↗
• InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF LCS COMPLETE REVISION COMPONENTS. IMPLANTS REVISED DUE TO SUSPECTED INFECTION AND LOOSENING. VERY MINIMAL BONE GROWTH ON THE STEM AND SLEEVE. IMPLANTS WERE REMOVED VERY EASILY.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 20567721 ↗
• InjuryAug 9, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE LOOSENING INTERFACE WAS CEMENT INTERFACE.

  Patient problems: Insufficient Information

  MAUDE report 19949304 ↗
• InjuryMay 1, 2024Adverse 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 PROGRESSIVE PAIN AND RECURRENT HEMARTHROSIS RIGHT KNEE. BONE SCAN IMPLIED COMPONENTS MAY BE LOOSE. THEY WERE NOT. DOI: (B)(6) 2019. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 19221263 ↗
• InjuryMar 22, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO TIBIAL AND FEMORAL LOOSENING AT THE UNKNOWN INTERFACE. DOI: (B)(6) 2012. DOR: (B)(6) 2024. AFFECTED SIDE : LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18962820 ↗
• InjuryFeb 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED LEFT TOTAL KNEE. IMPLANTED DFR ON (B)(6), 2023 AND A POLY EXCHANGE ON (B)(6), 2023. PATIENT CAME INFECTED SO THEY EXPLANTED ALL IMPLANTS AND IMPLANTED A CEMENT SPACER USING ANTIBIOTIC SPACER AND EX-FIX RODS AND CONNECTOR. DOI: (B)(6), 2023. DOR: (B)(6), 2024. AFFECTED SIDE: LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 18776693 ↗
• InjuryFeb 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TIBIA REVISED DUE TO PAIN AND SWELLING. TIBIAL LOOSENING WAS NOT OBSERVED. NO INFECTION. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI: (B)(6) 2018. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 18711206 ↗
• InjuryFeb 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 18654961 ↗
• InjuryMay 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INCREASED KNEE PAIN AND DEEP INFECTION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2017. DATE OF EVENT: UNK 2019. (LEFT KNEE). TREATMENT: EXPLANT OF ALL COMPONENTS, EIGHT WEEKS OF ANTIBIOTICS (RE-IMPLANTATION OF COMPONENTS PLANNED AFTER ANTIBIOTIC TREATMENT).

  Patient problems: Pain; Unspecified Infection

  MAUDE report 16918947 ↗
• InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION OF RIGHT KNEE. ALL IMPLANTS WERE REMOVED. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16862264 ↗
• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PAIN AND STERLING AND WAS TESTED FOR NICKEL ALLERGY. THE TEST CAME BACK POSITIVE SO THE SURGEON TOOK IT ALL OUT AND PUT IN AN AESCULAP REVISION CONSTRUCT. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 16584848 ↗
• InjuryJan 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR KNEE SWELLING/HEMARTHROSIS. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2016. DATE OF EVENT: (B)(6) 2022. (LEFT KNEE). TREATMENT: ASPIRATED FOR BLOOD AND MILD CLOUDINESS; SENT FOR SYNOVASURE AND CAME BACK NEGATIVE FOR BOTH AEROBIC AND ANAEROBIC ORGANISM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Swelling/ Edema

  MAUDE report 16149538 ↗
• InjuryJan 3, 2023Migration; Migration

  IT WAS REPORTED THAT THE TIBIAL TRAY SUBSIDED. THE DOCTOR SAID THAT INSTABILITY WAS NOT THE PATIENT¿S ISSUE. PATIENT WAS HAVING PAIN. TIBIAL TRAY DID NOT APPEAR LOOSE DURING EXTRACTION. ORIGINAL IMPLANT DATE UNKNOWN. THE CEMENT MANUFACTURER WAS UNKNOWN. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 16087514 ↗
• InjuryOct 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO AN UNSTABLE KNEE. SURGEON EXPLANTED TIBIA REVISING WITH NEW MBT REV TRAY. THE CEMENT MANUFACTURER WAS NOT INDICATED. THERE WAS NO LOOSENING AND SURGICAL DELAY. DOI: (B)(6) 2018, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15640312 ↗
• InjuryApr 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO TREAT A METAL ALLERGY. DOR (B)(6) 2020.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 14021758 ↗
• InjuryDec 8, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT'S KNEE WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. DOI: (B)(6) 2021. DOR: (B)(6) 2021. RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 12962747 ↗
• InjuryNov 23, 2021Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A RIGHT KNEE REVISION TO ADDRESS INFECTION, PAIN, SWELLING, SYNOVITIS, REMOVAL OF FIBROUS TISSUE, AND TIBIAL COMPONENT LOOSENING. THE SURGEON HAD TO PERFORM A CORONAL PLANE OSTEOTOMY OF THE DISTAL FEMUR TO REMOVE THE WELL-FIXED FEMORAL COMPONENTS. THERE WAS NOTED TO BE REMOVAL OF CERCLAGE WIRES ON THE FEMUR THAT WERE PLACED PRIOR FOR AN UNKNOWN REASON ON AN UNKNOWN DATE. IT IS UNKNOWN IF THE WIRES WERE PREVIOUSLY PLACED DUE TO A COMPLICATION OR TO PREVENT ANY ISSUES.

  Patient problems: Adhesion(s); Pain; Swelling/ Edema; Synovitis; Unspecified Infection

  MAUDE report 12862915 ↗
• InjurySep 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED LAST (B)(6) 2021 DUE TO STAGE 1 INFECTION. SURGERY WAS DONE AT (B)(6) HOSPITAL. THE 1ST REVISION WAS DONE ON (B)(6) 2016. DOI: (B)(6) 2016, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12542230 ↗
• InjuryAug 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED TKA. REMOVED IMPLANTS THAT WERE IMPLANTED (B)(6) 2020. PERFORMED WASHOUT, I&D AND IMPLANTED A ANTIBIOTIC CEMENT SPACER. DOI: (B)(6) 2020 DOR: (B)(6) 2021 LEFT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12296720 ↗
• InjuryJul 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. ALL COMPONENTS WERE REMOVED. DOI: UNKNOWN, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12167649 ↗
• InjuryJul 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  11TH REVISION AND REMOVAL OF ALL PREVIOUS REVISION COMPONENTS TO TREAT LEFT KNEE SWELLING AND CONFIRMED INFECTION. PATIENT RECEIVED A TEMPORARY ATTUNE ANTIBIOTIC SPACER TO BE REMOVED WHEN THE INFECTION HAS CLEARED. DOI: (B)(6) 2020 (10TH REVISION AND IMPLANTATION OF REVISION PRODUCTS), DOR: (B)(6) 2021 (11TH REVISION AND REMOVAL OF ALL PRODUCTS), LEFT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Swelling/ Edema

  MAUDE report 12149717 ↗