BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX90 ARCOM 28MM HIWL LNR SZ 46

    MDR report key: 2992648 · Received March 7, 2013

    Report

    Report Number
    0001825034-2013-00520
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    April 15, 2013
    Report Date
    February 11, 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
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THE REASON FOR THE REVISION PROCEDURE AND PART IDENTIFICATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS REPORT IS NUMBER 1 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00520-1 AND 01349/1351).

    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. DATE OF EVENT - UNKNOWN, EXPIRATION DATE - UNKNOWN, DATE IMPLANTED - UNKNOWN, DATE EXPLANTED - UNKNOWN, PMA/510(K) NUMBER - UNKNOWN, MANUFACTURE DATE - UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY IN 1995. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO DISLOCATION. IT WAS NOTED X-RAYS APPEARED TO SHOW THE CEMENT MANTLE APPEARED FRACTURED IN THE FEMUR. THE STEM, HEAD, LINER AND CEMENT WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP ARTHROPLASTY IN THE MID 1990'S. SUBSEQUENTLY, THE PATIENT IS HAVING PROBLEMS WITH DISLOCATION. A REVISION HAS NOT BEEN SCHEDULED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96968 RX90 ARCOM 28MM HIWL LNR SZ 46 PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 181870

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R