BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MLRY-HD XR LAT POR FMRL 8MM

    MDR report key: 10443368 · Received August 24, 2020

    Report

    Report Number
    0001825034-2020-03304
    Event Type
    Injury
    Date Received
    August 24, 2020
    Date of Event
    August 4, 2020
    Report Date
    October 20, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    NOT CLEARED
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: B4, B5, G4, H2, H3, H6. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT 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 DEVICES: 139254 M2A-MAGNUM 42-50MM TPR INSRT 631620; 157444 M2A-MAGNUM MOD HD SZ 44MM 915400; US157850 M2A-MAGNUM PF CUP 50ODX44ID 342640. REPORT SOURCE: (B)(6). PMA/510K: THIS PRODUCT IS NOT APPROVED IN US, BUT IS SAME/SIMILAR TO 510K (K021403). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2020 - 03303.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT HIP REVISION APPROXIMATELY TEN YEARS POST IMPLANTATION DUE TO OSTEOLYSIS. DURING THE PROCEDURE, ALL COMPONENTS WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906443 MLRY-HD XR LAT POR FMRL 8MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 145290

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R