BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RINGLOC LINER 28MM 10 DEG 24

    MDR report key: 2860799 · Received December 6, 2012

    Report

    Report Number
    0001825034-2012-02553
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 20, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK920640
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. PRODUCT IDENTIFICATION & EXPIRATION DATE - UNKNOWN. DATE IMPLANTED - UNKNOWN. MANUFACTURE DATE - UNKNOWN. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO CORRECT THE ITEM NUMBER BASED ON ADDITIONAL INFORMATION RECEIVED. THE FOLLOWING SECTIONS WERE UPDATED AS A RESULT: BRAND NAME AND PRODUCT CODE CATALOGUE NUMBER, 510(K) NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY IN 1997. A SUBSEQUENT REVISION WAS PERFORMED (B)(6) 2012 DUE TO ACETABULAR LINER WEAR. THE LINER AND HEAD WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RINGLOC LINER 28MM 10 DEG 24 PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R