BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CEMENTRALIZER 10.0MM

    MDR report key: 10836802 · Received November 13, 2020

    Report

    Report Number
    1818910-2020-24570
    Event Type
    Injury
    Date Received
    November 13, 2020
    Date of Event
    October 29, 2020
    Report Date
    October 29, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDK
    UDI-DI
    10603295034568
    PMA / PMN Number
    K871510
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 PER WI-3430, A MANUFACTURING REVIEW (MRE) IS UNLIKELY TO ADD VALUE TO THE COMPLAINT INVESTIGATION REGARDING AN ALLEGATION OF PAIN. MRE NOT REQUESTED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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 JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, 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.

    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

    THE PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2019. DOR: (B)(6) 2020; AFFECTED: RIGHT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1301156 CEMENTRALIZER 10.0MM HIP MISCELLANEOUS : CEMENT CENTRALIZER/PLUG JDK DEPUY ORTHOPAEDICS INC US 1376-48-000 J0808N 10603295034568

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ARTICUL/EZE BALL 32 +5 BR| PROSTALAC ACET CUP 42X32| PROSTALAC HIGH 105MM STEM SZ1| ARTICUL/EZE BALL 32 +5 BR| PROSTALAC ACET CUP 42X32| PROSTALAC HIGH 105MM STEM SZ1