BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CEMENTRALIZER 10.0MM

    MDR report key: 11672343 · Received April 15, 2021

    Report

    Report Number
    1818910-2021-08032
    Event Type
    Injury
    Date Received
    April 15, 2021
    Date of Event
    March 31, 2021
    Report Date
    March 31, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDK
    UDI-DI
    10603295034568
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED, AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT : THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MATERIAL, MANUFACTURING, INSPECTION OR STERILE PROCESSING THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND A CEMENT SPACER WAS PLACED. THE PATIENT'S ORIGINAL TOTAL HIP WAS DONE (B)(6) 2020 AND HE HAD AN I&D WASHOUT, HEAD LINER EXCHANGE, ON (B)(6) 2020. DOI: (B)(6) 2020; DOR: (B)(6) 2021; AFFECTED SIDE: LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572585 CEMENTRALIZER 10.0MM HIP MISCELLANEOUS : CEMENT CENTRALIZER/PLUG JDK DEPUY ORTHOPAEDICS INC US 1376-48-000 J4732A 10603295034568

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention ALTRX NEUT 36IDX52OD| CEMENTRALIZER 10.0MM| DLT TS CER HD 12/14 36MM +5.0| PINN CAN BONE SCREW 6.5MMX20MM| PINNACLE SECTOR II CUP 52MM| SUMMIT CEMENTED STEM SZ5 STD| ALTRX NEUT 36IDX52OD| CEMENTRALIZER 10.0MM| DLT TS CER HD 12/14 36MM +5.0| PINN CAN BONE SCREW 6.5MMX20MM| PINNACLE SECTOR II CUP 52MM| SUMMIT CEMENTED STEM SZ5 STD