BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RINGLOC+ REGENEREX CUP

    MDR report key: 3026062 · Received March 28, 2013

    Report

    Report Number
    0001825034-2013-00786
    Event Type
    Injury
    Date Received
    March 28, 2013
    Date of Event
    February 21, 2013
    Report Date
    March 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
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED DATA. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00786-1 / 00787-1).

    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. MANUFACTURE DATE - UNKNOWN. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00786 / 00787).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A HIP ARTHROPLASTY ON AN UNKNOWN DATE WITH UNKNOWN PRODUCTS. SUBSEQUENTLY, PATIENT WAS REVISED ON AN UNKNOWN DATE DUE TO PAIN AND MALALIGNED CUP. THE CUP WAS REMOVED AND REPLACED WITH A BIOMET CUP. ON (B)(6) 2011, PATIENT WAS REVISED DUE TO INSTABILITY AND THE HEAD AND STEM WERE REPLACED WITH COMPETITOR PRODUCT AND A BIOMET LINER WAS IMPLANTED. ON (B)(6) 2013, THE PATIENT WAS REVISED DUE TO INFECTION. ALL PRODUCTS WERE REMOVED AND ANTIBIOTIC SPACERS WERE IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A HIP ARTHROPLASTY ON AN UNKNOWN DATE WITH COMPETITOR PRODUCTS. SUBSEQUENTLY, PATIENT WAS REVISED ON AN UNKNOWN DATE DUE TO PAIN AND MALALIGNED CUP. THE CUP WAS REMOVED AND REPLACED WITH A BIOMET CUP. ON (B)(6) 2011, PATIENT WAS REVISED DUE TO INSTABILITY AND THE HEAD AND STEM WERE REPLACED WITH COMPETITOR PRODUCT AND A BIOMET LINER WAS IMPLANTED. ON (B)(6) 2013, THE PATIENT WAS REVISED DUE TO INFECTION. ALL PRODUCTS WERE REMOVED AND ANTIBIOTIC SPACERS WERE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129346 UNKNOWN RINGLOC+ REGENEREX CUP PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R