BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 48ODX42ID

    MDR report key: 10270837 · Received July 14, 2020

    Report

    Report Number
    0001825034-2020-02730
    Event Type
    Injury
    Date Received
    July 14, 2020
    Date of Event
    April 18, 2011
    Report Date
    September 23, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K101336
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    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 CONFIRMED BY REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. MEDICAL RECORDS IDENTIFIED THE FOLLOWING: SWELLING, PRE-OP LABS NEGATIVE FOR INFECTION. SLIGHT ELEVATED CHROME ION LEVEL ¿ NO LEVELS PROVIDED. LARGE CYSTIC MASS APPROXIMATE SIZE OF TENNIS BALL IN SUBCUTANEOUS TISSUE- CHALKY APPEARANCE, WHITE-YELLOW PASTE LIKE MATERIAL ¿ ALL CYSTIC LESION WAS EXCISED, SENT TO LAB/PATHOLOGY ¿ NO RESULTS. ACETABULUM COMPONENT WAS FOUND WITHOUT BONEY INGROWTH, AND WAS HELD BY FIBROUS TISSUE. NECROTIC DEBRIS FOUND WITHIN THE JOINT. NEW SHELL PLACED WITH BONE SCREWS, WELL-FIXED STEM NOTED. 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 PRODUCTS: 157442 M2A-MAGNUM MOD HD SZ 42MM 42MM 070190. 103201 TAPERLOC POR FMRL 6.0X132 340950. 139252 M2A-MAGNUM 42-50MM TPR INSRT-6 760000. 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: 0001825034-2020-02731.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT RIGHT HIP REVISION APPROXIMATELY THREE YEARS POST IMPLANTATION DUE TO INCREASED CHROME ION LEVELS. DURING THE PROCEDURE, A LARGE CYSTIC LESION WAS NOTED IN THE SUBCUTANEOUS TISSUE WITH CONTINUOUS WITH ORIGIN FROM THE POSTERIOR HIP JOINT. ACETABULAR DEVICE WAS NOTED TO BE WITHOUT BONE INGROWTH AND FIXED TO THE PELVIS BY FIBROUS TISSUE. HEAD AND CUP 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
    733892 M2A-MAGNUM PF CUP 48ODX42ID PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 549250

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R