BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMEX SHELL PC DIA48MM LN 22

    MDR report key: 5262479 · Received December 2, 2015

    Report

    Report Number
    3002806535-2015-04113
    Event Type
    Injury
    Date Received
    December 2, 2015
    Date of Event
    August 19, 2015
    Report Date
    January 28, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. 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 OR DEVIATION. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K921181. EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    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. EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. DURING THE EVALUATION, IT WAS NOTED THE ROOT CAUSE OF THE EVENT WAS MOST LIKELY ATTRIBUTED TO THE DURATION OF PRODUCT BEING IMPLANTED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 14 STATES, "FATIGUE FRACTURE OF COMPONENT CAN OCCUR AS A RESULT OF LOSS OF FIXATION, STRENUOUS ACTIVITY, MALALIGNMENT, TRAUMA, NON-UNION, OR EXCESSIVE ACTIVITY. NUMBER 16 STATES, "WEAR AND/OR DEFORMATION OF ARTICULATING SURFACES." THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 3002806535-2015-04113 AND 0001825034-2015-03913).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2002. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2015 DUE TO FRACTURED ACETABULAR LINER AND DAMAGED ACETABULAR SHELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792092 BIOMEX SHELL PC DIA48MM LN 22 PROSTHESIS, HIP LZO BIOMET UK LTD. N/A 313077

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R