BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 3782292 · Received April 30, 2014

    Report

    Report Number
    0001825034-2014-03480
    Event Type
    Injury
    Date Received
    April 30, 2014
    Report Date
    September 18, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PUNK
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    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. THIS REPORT IS NUMBER 3 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-00572-1 / 00573-1 / 03480-1).

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED AS LIMITED INFORMATION WAS AVAILABLE: PRODUCT IDENTIFICATION & EXPIRY DATE, IMPLANT DATE, MANUFACTURE DATE. THIS REPORT IS NUMBER 3 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-00572 & 00573 & 03480).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL RIGHT HIP ARTHROPLASTY ON AN UNKNOWN DATE IN 1979. IT WAS FURTHER REPORTED PATIENT UNDERWENT REVISION PROCEDURES ON UNKNOWN DATES IN 1991 AND 1998. PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2007 DUE TO ACETABULAR WEAR, OSTEOLYSIS AND FEMORAL LOOSENING. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2008 DUE TO INFECTION. AN IRRIGATION AND DEBRIDEMENT WAS COMPLETED AND THE ACETABULAR LINER AND MODULAR HEAD WERE REPLACED DURING THE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259617 UNKNOWN PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R