BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR MODULAR HEAD

    MDR report key: 8107654 · Received November 27, 2018

    Report

    Report Number
    0001825034-2018-10876
    Event Type
    Injury
    Date Received
    November 27, 2018
    Date of Event
    October 23, 2017
    Report Date
    July 29, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K960303
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. REVISION OP NOTES WERE REVIEWED AND IDENTIFIED PATIENT WAS REVISED DUE TO FAILED CONSTRAINT LINER WITH DISLOCATION OF LEFT TOTAL HIP, FROM DOCUMENTED CHRONIC IMPINGEMENT AND MALALIGNMENT OF THE CUP. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: M2A-MAGNUM PF CUP # ITEM 072830 LOT 072830, UNK CONSTRAINED LINER. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-10875, AND 0001825034-2018-10877. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION PROCEDURE APPROXIMATELY SEVEN YEARS POST INITIAL SURGERY DUE TO IMPLANT FRACTURE, DISLOCATION, IMPINGEMENT AND MALPOSITION. THE CUP, LINER AND HEAD WERE REVISED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945824 COCR MODULAR HEAD PROSTHESIS HIP LPH ZIMMER BIOMET, INC. N/A 196450

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R