BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELEX/MAGNUM MOD HD 40MM +6

    MDR report key: 4919754 · Received July 16, 2015

    Report

    Report Number
    0001825034-2015-03055
    Event Type
    Injury
    Date Received
    July 16, 2015
    Report Date
    July 15, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    PK062997
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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 OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES." THIS REPORT IS NUMBER 3 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2015-03053 & 03054 & 03055).

    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 BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 3 OF 4 MDRS FILED FOR THE SAME PATIENT (REFERENCE 825034-2015-03053 / 03055 & 2016-04094).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS - TAPERLOC FEMORAL STEM CATALOG#: 103207 LOT#: 220990, MAGNUM FEMORAL HEAD CATALOG#: 157450 LOT#: 468360, MAGNUM TAPER ADAPTER CATALOG#: 139258 LOT#: 598590. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED SO NO PRODUCT EVALUATION COULD BE CONDUCTED. THIS DEVICE WAS USED FOR TREATMENT. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT REPORTED THAT PATIENT UNDERWENT A REVISION PROCEDURE ON THE CONTRALATERAL SIDE DUE TO ELEVATED METAL ION LEVELS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2015 DUE TO ELEVATED METAL ION LEVELS. DURING THE PROCEDURE, THE LINER WOULD NOT LOCK INTO THE ACETABULAR CUP. ANOTHER LINER WAS USED TO COMPLETE THE PROCEDURE. THE ACETABULAR CUP, MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE APPROXIMATELY SEVEN YEARS POST-IMPLANTATION DUE TO METALLOSIS, ELEVATED METAL ION LEVELS AND PAIN. DURING THE PROCEDURE, CLEAR YELLOW FLUID, STAINED TISSUE, PSEUDOTUMOR FORMATION AND OSTEOLYSIS WERE NOTED. THE FEMORAL HEAD, TAPER ADAPTER AND ACETABULAR CUP WERE REMOVED AND REPLACED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462346 SELEX/MAGNUM MOD HD 40MM +6 PROSTHESIS, HIP LZO BIOMET ORTHOPEDICS N/A 430110

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention