BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-38 CUP NON FLARED SZ 56MM

    MDR report key: 7936046 · Received October 4, 2018

    Report

    Report Number
    0001825034-2018-02876
    Event Type
    Injury
    Date Received
    October 4, 2018
    Date of Event
    September 2, 2014
    Report Date
    October 3, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. CONCOMITANT MEDICAL PRODUCTS: ITEM NUMBER: 650-1055, ITEM NAME: DELTA CERAMIC OPTION HEAD DIA2 8, LOT #: 986880. ITEM NUMBER: 650-1067, ITEM NAME: CER OPTION TYPE 1 TPR SLEVE +3 PE 1, LOT #: 131600. ITEM NUMBER: EP-200144, ITEM NAME: ACT ARTIC E1 HIP BRG 28X38MM S44 DIA28, LOT #: 694930. ITEM NUMBER: X180311, ITEM NAME: BI-METRIC/X POR NC 11X135, LOT #: 248120. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 09413; 0001825034 - 2018 - 09414 ; 0001825034 - 2018 - 09415. 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 DURING A REVISION SURGERY, THE PATIENT EXPERIENCED A BLOOD LOSS OF 1200CC. OPERATIVE NOTES STATE THAT THERE WAS A STEADY OOZE OF BLEEDING FROM THE ACETABULAR COMPONENT RESULTING IN SOME INCREASED BLOOD LOSS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775974 M2A-38 CUP NON FLARED SZ 56MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 541500

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| O