BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIV 2-HOLE SHL 56MM LNR SZ 24

    MDR report key: 3882308 · Received June 18, 2014

    Report

    Report Number
    0001825034-2014-05619
    Event Type
    Injury
    Date Received
    June 18, 2014
    Report Date
    October 15, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MEH
    PMA / PMN Number
    PK092130
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    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 RELATED TO THE EVENT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 2 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-03963 /-03964 /-05606).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007 AND A REVISION PROCEDURE ON (B)(6) 2008 DUE TO PATIENT ALLEGATIONS OF PAIN, INFLAMMATION, DYSFUNCTION, LOSS OF RANGE OF MOTION, METAL POISONING, METALLOSIS, LACK OF MOBILITY, SWELLING, DAMAGE TO SURROUNDING BONE AND TISSUE AND ELEVATED METAL ION LEVELS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED NOTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2011. OPERATIVE REPORT RECEIVED FOR THE (B)(6) 2008 LEFT HIP REVISION NOTED THE REVISION WAS DUE TO PAIN, AVULSION OF ABDUCTOR TENDON, AND LEG LENGTH DISCREPANCY. OPERATIVE REPORT FURTHER NOTES THE FAILURE OF THE PREVIOUS ABDUCTOR TENDON REPAIR AND IMPINGEMENT OF ILIOPSOAS TENDON. THE ACETABULAR CUP AND MODULAR HEAD WERE REMOVED AND REPLACED WITH A COMPETITOR¿S CUP AND A BIOMET HEAD. NO REVISION HAS BEEN REPORTED FOR THE RIGHT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358172 UNIV 2-HOLE SHL 56MM LNR SZ 24 PROSTHESIS, HIP MEH BIOMET ORTHOPEDICS N/A 642650

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization