BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MOD HD STD NK

    MDR report key: 3863642 · Received June 10, 2014

    Report

    Report Number
    0001825034-2014-05334
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 9, 2014
    Report Date
    October 14, 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. FOLLOW UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION PERTAINING TO EVENT DETAILS AND PRODUCT IDENTIFICATION ARE IN PROCESS. SHOULD ADDITIONAL INFORMATION BE RECEIVED, BIOMET WILL FORWARD A SUPPLEMENTAL REPORT TO THE FDA. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. PRODUCT IDENTIFICATION AND EXPIRATION DATE - UNKNOWN. MANUFACTURE DATE ¿ UNKNOWN. PRODUCT IS BEING RETURNED TO MANUFACTURER, BUT HAS NOT YET BEEN RECEIVED. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION.

    Additional Manufacturer Narrative · 1

    THE RETURNED PRODUCT WAS EVALUATED AND WAS FOUND TO HAVE BEEN MANUFACTURED WITHIN SPECIFICATIONS. A VISUAL EXAMINATION OF THE RECEIVED HEAD AND CUP APPEARED TO SHOW EVIDENCE OF SUBLUXATION OF THE JOINT, SCRATCHING OF THE BEARING SURFACES, AND TAPER FRETTING. A SMALL REGION OF POROUS COATING WAS MISSING FROM THE CUP; HOWEVER, IT COULD NOT BE DETERMINED WHETHER THIS COATING REMOVAL OCCURRED BEFORE OR DURING REMOVAL SURGERY. MEASUREMENTS WERE WITHIN THE NORMAL WEAR FOR AN IMPLANT THAT HAS BEEN IN FOR 7 YEARS.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT AN INITIAL HIP ARTHROPLASTY ON (B)(6) 2007. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2014 FOR UNKNOWN REASONS.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT AN INITIAL HIP ARTHROPLASTY ON (B)(6) 2007. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2014 FOR UNKNOWN REASONS. ADDITIONAL INFORMATION ON PRODUCT IDENTIFICATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337867 M2A 38MM MOD HD STD NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 400090

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R