BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RANAWAT/BURSTEIN RINGLOC SHELL

    MDR report key: 6754484 · Received July 31, 2017

    Report

    Report Number
    0001825034-2017-05257
    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
    PK911685
    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 28 MM HIGH WALL LINER SIZE 24, CATALOG#: 105904, LOT#: 176510, 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: 0001825034-2017-05263. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DESIGN HISTORY RECORDS WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 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
    534054 RANAWAT/BURSTEIN RINGLOC SHELL PROSTHESIS HIP JDI BIOMET ORTHOPEDICS N/A 968600

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R