BEUDAMED
    FDA Adverse Event Summary report: N

    CER BIOLOXD OPTION HD 36MM

    MDR report key: 6045211 · Received October 20, 2016

    Report

    Report Number
    3002806535-2016-00792
    Date Received
    October 20, 2016
    Date of Event
    December 7, 2015
    Report Date
    October 5, 2017
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    PK051411
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    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. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET US 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 K051411. THIS REPORT IS NUMBER 5 OF 5 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-04212 / 04213 AND 3002806535-2016-00792 AND 0001822565-2016-03782 AND 0002648920-2016-03222).

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO NOT BE REPORTABLE. THERE ARE NO ALLEGATIONS OF FAILURE OF THE DEVICE AND THE INITIAL REPORT WAS SUBMITTED IN ERROR.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT WHO UNDERWENT A HIP REVISION APPROXIMATELY 5 YEARS POST-IMPLANTATION REPORTED PATIENT ALLEGATIONS OF PAIN AND TRUNIONOSIS, AND YELLOW NECROTIC TISSUE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. OPERATIVE REPORTS STATE THAT THE PATIENT HAD EFFUSION IN THE HIP JOINT. THERE WAS WEAR OF THE ACETABULAR LINER WITH THE ACETABULAR COMPONENT AT A 0-10 DEGREE ANTEVERTED POSITION. LYSIS WAS NOTED IN THE ISCHIUM AND ANTERIOR-SUPERIOR ACETABULUM AND PELVIS WITH LESIONS OF GREATER THAN 4CM. THE FEMUR WAS NOTED AS HAVING A GREATER THAN 4CM PROXIMAL CIRCUMFERENTIAL LYSIS. THE TRUNNION WAS NOTED AS HAVING CORROSION. THERE WAS ALSO NOTED TO BE PSEUDOPODS OF BONY INGROWTH IN THE ACETABULUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695710 CER BIOLOXD OPTION HD 36MM PROSTHESIS, HIP LZO BIOMET UK LTD. N/A 730810

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R