BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RANAWAT/BURSTEIN COCR CEMENT FEMORAL STEM SIZE 6

    MDR report key: 6754482 · Received July 31, 2017

    Report

    Report Number
    0001825034-2017-05263
    Event Type
    Injury
    Date Received
    July 31, 2017
    Date of Event
    July 12, 2017
    Report Date
    September 8, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK911684
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: RANAWAT/BURSTEIN SHELL POROUS, CATALOG#: 106056, LOT#: 968600, RANAWAT/BURSTEIN FEMORAL STEM CEMENT SIZE 6,CATALOG#: 105806, LOT#: 940860, RANAWAT/BURSTEIN CENTRALIZER CEMENT SIZE 6, CATALOG#: 105816, LOT#: 072090. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-05257. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED, PRODUCT LOCATION UNKNOWN TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT THIS DEVICE WAS NOT INVOLVED IN THE EVENT AND SHOULD NOT HAVE BEEN REPORTED. THE INITIAL REPORT SHOULD BE VOIDED AS IT WAS SUBMITTED IN ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A REVISION OF RANAWAT BURSTEIN HIP ABOUT 22 YEARS POST IMPLANT, DUE TO OSTEOLYSIS AND MASSIVE BONE LOSS OF THE ACETABULUM. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534053 RANAWAT/BURSTEIN COCR CEMENT FEMORAL STEM SIZE 6 PROSTHESIS HIP JDI BIOMET ORTHOPEDICS N/A 940860

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R