BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BI-METRIC/X POR NC 13X145

    MDR report key: 9560173 · Received January 7, 2020

    Report

    Report Number
    0001825034-2020-00050
    Event Type
    Injury
    Date Received
    January 7, 2020
    Date of Event
    June 10, 2019
    Report Date
    January 16, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    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 58ODX52ID, PN US157858, LN 394870, M2A-MAGNUM MOD HD SZ 52MM, PN 157425, LN 203070, M2A-MAGNUM 52-60MM TPR INS STD, PN 139268, LN 810490. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034-2019-00539, 0001825034-2019-00540. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION APPROXIMATELY 14 YEARS AFTER THE INITIAL SURGERY DUE TO PAIN, PSEUDOTUMOR, ACETABULAR PROTRUSIO, AND ELEVATED METAL IONS. DURING THE REVISION, EXTENSIVE METALLOSIS, SCAR TISSUE, AND TISSUE DAMAGE WERE NOTED IN ADDITION TO SIGNIFICANT BONE LOSS AND OSTEOLYSIS. ALL COMPONENTS WERE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21160 BI-METRIC/X POR NC 13X145 PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 517600

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10 NARRATIVE.