BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK ATTUNE KNEE PATELLA

    MDR report key: 23595312 · Received November 19, 2025

    Report

    Report Number
    1818910-2025-20322
    Event Type
    Injury
    Date Received
    November 19, 2025
    Date of Event
    August 13, 2025
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL MANUFACTURER NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY- NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THIS COMPLAINT WAS OPENED TO DOCUMENT COMPLAINTS DERIVED THROUGH A JOURNAL ARTICLE REVIEW. FOLLOW-UPS WERE DONE TO TRY AND OBTAIN ADDITIONAL INFORMATION FROM THE AUTHOR OF THE JOURNAL ARTICLE. NO FURTHER INFORMATION WAS RECEIVED. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT- THE DEVICE LOT NUMBER IS UNKNOWN, THEREFORE A¿DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. IF THE LOT/SERIAL NUMBER BECOMES AVAILABLE, THE RECORD WILL BE RE-ASSESSED.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED AYOB KA, JAGOTA I, TWIGGS J, LIU DW. CEMENTLESS TIBIAL FIXATION RESULTS IN SLOWER RECOVERY BUT EQUIVALENT OUTCOME AT 12 MONTHS IN PRIMARY TOTAL KNEE ARTHROPLASTY. ARTHROPLAST TODAY. 2025 AUG 13;35:101792. DOI: 10.1016/J.ARTD.2025.101792. PMID: 40837113; PMCID: PMC12362381. OBJECTIVE/METHODS/STUDY DATA: THE PURPOSE OF THIS STUDY IS TO DETERMINE IF THERE WERE ANY DIFFERENCES IN THE RECOVERY PATH AND EARLY SURVIVORSHIP BETWEEN THE FULLY CEMENTED AND REVERSE HYBRID TKA USING A CEMENTLESS TIBIAL BASEPLATE OF THE SAME DESIGN. THE STUDY MATCHED 82 KNEES IN THE CEMENTED TIBIAL GROUP AND 82 KNEES IN THE CEMENTLESS TIBIAL GROUPS (82 MALES & 82 FEMALES; MEAN AGE: 69.83 ± 7.01) WERE INCLUDED IN THE STUDY. IN THE CEMENTED GROUP, 59 (71.95%) WERE PERFORMED WITH NAVIGATION (BRAINLAB KNEE 3 NAVIGATION, MUNICH, GERMANY), WHEREAS 58 (70.73%) WERE CONDUCTED WITH NAVIGATION IN THE CEMENTLESS COHORT. THE REMAINDER OF CASES WERE PERFORMED WITH ROBOTIC ASSISTANCE, USING VELYS ROBOTIC-ASSISTED SOLUTION (J AND J MEDTECH, WARSAW, INDIANA). ALL PATIENTS RECEIVED THE SAME ROTATING PLATFORM, POSTERIOR STABILIZED PROSTHESIS (ATTUNE, J AND J MEDTECH, WARSAW, INDIANA). IN THE CEMENTED COHORT, THE FEMUR, TIBIA AND PATELLA WERE FIXED WITH PALACOS R + G BONE CEMENT (HERAUS, HANAU, GERMANY). THE CEMENTLESS COHORT RECEIVED AN IDENTICAL CEMENTED FEMORAL AND PATELLA COMPONENT, WITH A PRESS-FIT TIBIAL COMPONENT MADE OF COBALT CHROMIUM (CO-CR) WITH SINTERED BEAD COATING. THE MEAN FOLLOW-UP WAS 2 YEARS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY ATTUNE OTHER DEVICES THAT WERE USED ON THE PATIENT AT THE TIME OF THE EVENT: PALACOS R + G BONE CEMENT (HERAUS, HANAU, GERMANY) - FOR CEMENTED COHORT ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK KNEE CONSTRUCT ATTUNE (QTY 5): (N=1) READMISSION IN THE CEMENTED GROUP FOR PERSISTENT WOUND OOZE. THIS RESOLVED WITH REST AND ANTIBIOTICS, WITHOUT THE NEED FOR REOPERATION AND THE PATIENT WAS DISCHARGED 7 DAYS AFTER READMISSION. (N=1) ANOTHER PATIENT IN THE CEMENTED GROUP DEVELOPED A COMPLEX REGIONAL PAIN SYNDROME, NECESSITATING REFERRAL TO A PAIN SPECIALIST. THE PATIENT¿S COMPLEX REGIONAL PAIN SYNDROME RESOLVED BY 12 MONTHS AND SHE WAS SATISFIED WITH THE RESULT. (N=3) 1 PATIENT IN THE CEMENTED GROUP & 2 PATIENTS IN THE CEMENTLESS GROUP REQUIRING MANIPULATION UNDER ANESTHESIA, PERFORMED BETWEEN 4-8 MONTHS AFTER SURGERY. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK ATTUNE FEMORAL (QTY 1): (N=1) PATELLA CLUNK DUE TO A PERIPATELLAR NODULE; ARTHROSCOPIC DEBRIDEMENT WAS PERFORMED IN THE CEMENTED TIBIA GROUP AT POSTOPERATIVE 8 MONTHS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK ATTUNE KNEE PATELLA (QTY 1): (N=1) PATELLA CLUNK DUE TO A PERIPATELLAR NODULE; ARTHROSCOPIC DEBRIDEMENT WAS PERFORMED IN THE CEMENTED TIBIA GROUP AT POSTOPERATIVE 8 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1494182 UNK ATTUNE KNEE PATELLA KNEE IMPLANT PATELLA JWH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention