BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A ACETABULAR SYSTEM

    MDR report key: 6463368 · Received April 6, 2017

    Report

    Report Number
    0001825034-2017-02086
    Event Type
    Injury
    Date Received
    April 6, 2017
    Date of Event
    September 19, 2016
    Report Date
    September 27, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCTS - BI-METRIC/X POR NC 9X125 / PN X180309 / PN 956440, M2A 38MM MOD HD STD NK / PN 11-173662 / LN 093260. 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 0001825034-2017-02084. -

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND ASSOCIATED RISKS ARE ADDRESSED IN RISK DOCUMENTATION. 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. INITIAL MEDWATCH WAS SUBMITTED WITH A NOTIFICATION DATE OF (B)(6) 2017 AND SUBMITTED ON (B)(6) 2017; HOWEVER THE CORRECT NOTIFICATION DATE IS (B)(6) 2017. 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 A PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 12 YEAR POST IMPLANTATION DUE TO PAIN, PSEUDOTUMOR, WALL THICKENING, METALLOSIS, AND ELEVATED METAL IONS. IT WAS ALLEGED THAT THERE WAS ATROPHY OF PELVIC AND HIP MUSCLES AND SCALLOPING ALONG THE RIGHT FEMORAL SHAFT WHEN THE PSEUDOTUMOR WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244827 M2A ACETABULAR SYSTEM HIP PROSTHESIS KWA BIOMET ORTHOPEDICS N/A 077170

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R