BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MODULAR HEAD

    MDR report key: 8830604 · Received July 26, 2019

    Report

    Report Number
    0001825034-2019-03230
    Event Type
    Injury
    Date Received
    July 26, 2019
    Report Date
    September 19, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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). THE FOLLOWING SECTIONS COULD NOT BE COMPLETED BECAUSE THE PART/LOT INFORMATION COULD BE: LOT NUMBER - 409780; EXPIRATION DATE - AUG 31, 2017; IMPLANT DATE - (B)(6) 2007; MANUFACTURING DATE - AUG 31, 2007. OR THE PART/LOT INFORMATION COULD BE: LOT NUMBER - 361870; EXPIRATION DATE - OCT 31, 2017; IMPLANT DATE - (B)(6) 2007; MANUFACTURING DATE - OCT 31, 2007. CONCOMITANT MEDICAL PRODUCTS: US157852 M2A-MAGNUM PF CUP 160870;  11-103205 TAPERLOC POR LAT FMRL 474420;  139259 M2A MAGNUM TPR INSERT 356450; US157852 M2A-MAGNUM PF CUP 538170;  11-103206 TAPERLOC POR LAT FMRL 461790; 139259 M2A MAGNUM TPR INSERT 765530. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, [ADD REASON, AS AVAILABLE]. 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: 0001825034-2019-03232.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, APPROXIMATELY TWELVE YEARS POST OPERATION THE PATIENT WAS REVISED DUE TO AN UNKNOWN REASON. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626229 M2A-MAGNUM MODULAR HEAD PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R