BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E-POLY 36MM +3 HIWALL LNR SZ23

    MDR report key: 3946215 · Received July 21, 2014

    Report

    Report Number
    0001825034-2014-06311
    Event Type
    Injury
    Date Received
    July 21, 2014
    Date of Event
    July 21, 2014
    Report Date
    November 14, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MAY
    PMA / PMN Number
    PK090103
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. DEVICE AVAILABILITY - THE DEVICE IS REPORTED TO BE AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED BY BIOMET ORTHOPEDICS TO DATE. IN THE EVENT THAT THE DEVICE IS RECEIVED AND EVALUATED, A FOLLOW UP REPORT WILL BE SENT TO THE FDA TO PROVIDE RESULTS.

    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. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. EXPIRATION DATE - UNKNOWN. DATE IMPLANTED - UNKNOWN. PMA/510(K) NUMBER. MANUFACTURE DATE ¿ UNKNOWN.

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED COMPONENT SUGGESTS THAT THE FEMORAL COMPONENT(S) MAY HAVE IMPINGED ON THE LOW SIDE RIM OF THE LINER; THAT THE LINER MAY HAVE FRACTURED NEAR THE LOCKING RING GROOVE AND DISLOCATED FROM THE SHELL, POSSIBLY FOLLOWED BY FURTHER FRACTURE OF THE LINER. THE CAUSE OF THE FRACTURE CANNOT BE DETERMINED. ACCORDING TO THE REVIEW OF DEVICE HISTORY RECORDS, THE LOT WAS RELEASED WITH NO RECORDED ANOMALY OR DEVIATION AND THE PARTS LIKELY LEFT BIOMET CONFORMING.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, A REVISION PROCEDURE HAS BEEN INDICATED DUE TO POLY WEAR; HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2012. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2014 DUE TO A FRACTURED LINER CAUSING DISLOCATION. THE MODULAR HEAD, ACETABULAR CUP AND LINER WERE REMOVED AND REPLACED WITH A COMPETITOR CUP AND AND LINER AND A BIOMET HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424167 E-POLY 36MM +3 HIWALL LNR SZ23 PROSTHESIS, HIP MAY BIOMET ORTHOPEDICS N/A 098050

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention