BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM DIA COCR MOD HD +12MM NK

    MDR report key: 3021850 · Received March 26, 2013

    Report

    Report Number
    3002806535-2013-00044
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    February 4, 2013
    Report Date
    July 25, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDI
    PMA / PMN Number
    PK911684
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO PRODUCT HAS BEEN RETURNED TO DATE. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. EXPIRATION DATE - UNKNOWN.MANUFACTURE DATE - UNKNOWN.ITEM IS TO BE RETURNED. UPON ITEM RETURN AND COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2014 FURTHER CLARIFYING THE PROCEDURE INFORMATION, IMPLANT/EXPLANT DATES, AND ITEM/LOT NUMBERS INVOLVED. ALL FIELDS RELATED TO THIS NEW INFORMATION HAVE BEEN UPDATED IN THE MEDWATCH FORM. IT HAS BEEN INDICATED THAT NO PRODUCT WILL BE RETURNED FOR EVALUATION. THIS IS 1 OF 3 MEDWATCH REPORTS SUBMITTED FOR THE SAME EVENT. ALSO SEE NEW INITIAL MEDWATCH REPORTS: 1825034-2014-00996 AND 1825034-2014-01051 FILED BY WARSAW ORTHOPEDICS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PRIMARY HIP PROCEDURE ON (B)(6) 2006. REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013 DUE TO PAIN AND OSTEOLYSIS. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2013 DUE TO ELEVATED METAL ION LEVELS. OPERATIVE NOTES INDICATES PRESENCE OF A FLUID, MASS OF GRANULATION TISSUE AND OSTEOLYSIS. THE HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED. PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2013 DUE TO HEMATOMA AND LEG LENGTH DISCREPANCY. THE HEAD WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123739 28MM DIA COCR MOD HD +12MM NK PROSTHESIS, HIP JDI BIOMET UK LTD. N/A 0000366394

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R