BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE CONSTRUCT ATTUNE

    MDR report key: 20532040 · Received October 25, 2024

    Report

    Report Number
    1818910-2024-22198
    Event Type
    Injury
    Date Received
    October 25, 2024
    Date of Event
    August 2, 2024
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY ORTHOPAEDICS IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY ORTHOPAEDICS HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY ORTHOPAEDICS OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY ORTHOPAEDICS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H11 ADDITIONAL NARRATIVE: D2A: FULL COMMON DEVICE NAME: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT/LOT NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. 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: VAN KEULEN LZ, SONNEGA RJA, BAAS NRA, HOGERVORST T, MUEHLENDYCK C, BOURRAS P, TEN KATE TAJ, GALVAIN T, DIELEMAN S, VAN KAMPEN PM. EVALUATING TWO IMPLANT DESIGNS IN PATIENTS UNDERGOING PRIMARY TOTAL KNEE ARTHROPLASTY USING A NOVEL MEASURE OF EARLY OPTIMAL RECOVERY: A RETROSPECTIVE OBSERVATIONAL STUDY. MUSCULOSKELET SURG. 2024 AUG 2. DOI: 10.1007/S12306-024-00851-Z. EPUB AHEAD OF PRINT. PMID: 39093383. THE OBJECTIVE OF THIS STUDY IS TO EVALUATE THE OVERALL QUALITY OF CARE ACHIEVED IN THE STUDY GROUP COMPARED TO THE CONTROL GROUP USING A NOVEL, COMPOSITE, ALL-OR-NONE METRIC CALLED EARLY OPTIMAL RECOVERY (EOR). THE STUDY AIMS TO DETERMINE IF THERE IS A SIGNIFICANT DIFFERENCE IN EOR BETWEEN THE TWO TKA IMPLANTS, HYPOTHESIZING THAT THE STUDY GROUP WILL SHOW SUPERIOR RESULTS OVER THE CONTROL GROUP. A TOTAL OF 566 PATIENTS WERE INCLUDED IN THIS STUDY, OF WHICH 185 (32.7%) PATIENTS WERE INCLUDED IN THE STUDY GROUP. THE OVERALL MEAN (SD) AGE OF THE COHORT WAS 67 (8) YEARS AND 62.4% OF THE PATIENTS WERE FEMALE. PATIENTS AGED = 18 YEARS, WITH A BODY MASS INDEX (BMI)<35 KG/M2 AND AN AMERICAN SOCIETY OF ANESTHESIOLOGISTS (ASA)SCORE<III THAT UNDERWENT A UNILATERAL PRIMARY TKA BETWEEN JANUARY 2017 AND DECEMBER 2020 WERE INCLUDED IN THIS STUDY. THIS RETROSPECTIVE STUDY USED EOR TO EVALUATE TWO KNEE IMPLANTS, THE ATTUNE® KNEE SYSTEM (STUDY GROUP) AND THE LCS® COMPLETE KNEE SYSTEM (CONTROL GROUP), AT THE ORTHOPEDIC CENTER, BERGMAN CLINICS, RIJSWIJK, THE NETHERLANDS. BOTH IMPLANT DESIGNS WERE MANUFACTURED BY DEPUY SYNTHES, WARSAW, IN. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: ATTUNE® KNEE SYSTEM AND LCS® COMPLETE KNEE SYSTEM, DEPUY SYNTHES, WARSAW, IN. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK KNEE CONSTRUCT ATTUNE (QTY 7). (N=1) PATIENT HAD A THROMBOEMBOLIC EVENT, NO INTERVENTION PROVIDED. (N=1) PATIENT HAD A BLEEDING, NO INTERVENTION PROVIDED. (N=1) PATIENT HAD A TRAUMATIC PATELLAR FRACTURE AND A PERIOPERATIVE FEMUR CONDYLE FRACTURE, FOLLOWED BY RE-SURGERY. (N=1) PATIENT HAD A THROMBOPHLEBITIS, NO INTERVENTION PROVIDED. (N=1) PATIENT HAD A BLADDER RETENTION, NO INTERVENTION PROVIDED. (N=1) PATIENT HAD A MOBILIZATION OF KNEE ON OK, NO INTERVENTION PROVIDED. (N=1) PATIENT HAD A TRANSIENT ISCHEMIC ATTACK, NO INTERVENTION PROVIDED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK KNEE CONSTRUCT LCS (QTY 16). (N=4) PATIENT HAD A THROMBOEMBOLIC EVENT, NO INTERVENTION PROVIDED. (N=2) PATIENT HAD A BLEEDING, NO INTERVENTION PROVIDED. (N=1) PATIENT HAD A TRAUMATIC PATELLAR FRACTURE AND A PERIOPERATIVE FEMUR CONDYLE FRACTURE, FOLLOWED BY RE-SURGERY. (N=1) PATIENT HAD A PARTIAL RUPTURE PATELLAR TENDON, NO INTERVENTION PROVIDED. (N=2) PATIENTS HAD AN ARTHROFBROSIS FOLLOWED BY RE-SURGERY. (N=1) PATIENTS HAD AN INFECTION FOLLOWED BY RE-SURGERY. (N=1) PATIENT HAD AN INSERT REVISION DUE TO INSTABILITY FOLLOWED BY RE-SURGERY. (N=1) PATIENT HAD A BLADDER RETENTION, NO INTERVENTION PROVIDED. (N=2) PATIENT HAD A MOBILIZATION OF KNEE ON OK, NO INTERVENTION PROVIDED. (N=1) PATIENT HAD A GASTROINTESTINAL BLEEDING DUE TO USE DICLOFENAC, NO INTERVENTION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1812058 UNKNOWN KNEE CONSTRUCT ATTUNE PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL JWH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention