BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM RECAP CUP 56ODX50ID

    MDR report key: 8568682 · Received May 1, 2019

    Report

    Report Number
    3002806535-2019-00425
    Event Type
    Injury
    Date Received
    May 1, 2019
    Date of Event
    May 14, 2013
    Report Date
    August 28, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT RE-OPERATION TO CLEAN OUT HETEROTOPIC OSSIFICATION FROM SOFT TISSUE . NO IMPLANTS WERE REVISED.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: (B)(6). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: BI-METRIC POROUS FMRL 14X150MM , CATALOG #: 162254, LOT #:1252754, MEDICAL PRODUCT: M2A-MAGNUM MOD HD SZ 50MM, CATALOG #: 157450, LOT #: 1248673, MEDICAL PRODUCT: M2A-MAGNUM 42-50 TPR INSRT STD, CATALOG #: 139256, LOT #: 1243760. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2019-00424, 3002806535-2019-00426, 3002806535-2019-00427. 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 RE-OPERATION TO CLEAN OUT HETEROTOPIC OSSIFICATION FROM SOFT TISSUE . NO IMPLANTS WERE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363124 M2A-MAGNUM RECAP CUP 56ODX50ID HIP PROSTHESIS KWA BIOMET UK LTD. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R