BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MOD HD STD NK

    MDR report key: 3952995 · Received July 23, 2014

    Report

    Report Number
    0001825034-2014-06404
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    May 12, 2014
    Report Date
    September 24, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK062997
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. (B)(4).

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    THE RETURNED HEAD AND CUP WERE FOUND TO HAVE BEEN MANUFACTURED WITHIN SPECIFICATIONS. VISUAL EXAMINATION APPEARED TO SHOW EVIDENCE OF SUBLUXATION OF THE JOINT AND SCRATCHING OF THE BEARING SURFACES. IN ADDITION, A SMALL AREA OF POROUS COATING APPEARED TO BE MISSING. HOWEVER, IT COULD NOT BE DETERMINED WHETHER THIS BACKSIDE DAMAGE OCCURRED DURING OR PRIOR TO REVISION SURGERY. RELEVANT ARTICULATING AND STACK DIMENSIONS AND FEATURES WERE CHECKED. ALL MEASUREMENTS WERE WITHIN THE AS MANUFACTURED REQUIREMENTS. THERE IS NO INDICATION, WITH THE INFORMATION AVAILABLE, THAT THERE IS ANY NON-CONFORMANCE IN THE PRODUCTS AS MANUFACTURED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2014 DUE TO AN UNKNOWN REASON. DURING THE PROCEDURE, THE MODULAR HEAD AND ACETABULAR CUP WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430048 M2A 38MM MOD HD STD NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 996680

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R