BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HEXLOC CUP

    MDR report key: 3091272 · Received May 3, 2013

    Report

    Report Number
    0001825034-2013-01252
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 3, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. BRAND NAME - UNKNOWN. PRODUCT CODE - UNKNOWN. PRODUCT IDENTIFICATION & EXPIRATION DATE - UNKNOWN. DATE EXPLANTED - UNKNOWN . MANUFACTURE DATE 0- UNKNOWN. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH AS THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE IS (OR MAY BE) NEEDED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING A REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND FURTHER MEDWATCH REPORTS WILL BE SUBMITTED, IF NECESSARY.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON UNKNOWN DATE. A SUBSEQUENT REVISION WAS PERFORMED (B)(6) 2013, DUE TO MALPOSITIONED CUP. THE CUP, LINER AND HEAD WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194368 UNKNOWN HEXLOC CUP PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R