BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BI-METRIC/X POR COLLAR 13X145

    MDR report key: 9362454 · Received November 22, 2019

    Report

    Report Number
    0001825034-2019-05319
    Event Type
    Injury
    Date Received
    November 22, 2019
    Date of Event
    July 5, 2016
    Report Date
    January 13, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 157450 ¿ M2A MAGNUM HEAD ¿ 231430, US157856 ¿ M2A MAGNUM CUP ¿ 667860, 139258 ¿ M2A MAGNUM TAPER - 267030. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 -2016 -03067, 0001825034 -2019 -05320.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY 6 YEARS POST IMPLANTATION DUE TO PAIN, ELEVATED METAL ION LEVELS. DURING THE PROCEDURE, METALLOSIS AND THIN-WALLED PSEUDOTUMOR TYPE PRESENTATION WHICH EXTENDED FROM THE GREAT TROCHANTERIC BURSAL REGION DOWN INTO THE POSTERIOR CAPSULE TO THE JOINT. THERE WAS ALSO NOTED TISSUE DAMAGE AND DESTRUCTION OF THE CENTRAL HALF OF THE GLUTEUS MEDIUS ATTACHMENT TO THE GREATER TROCHANTER AND THE CUP APPEARED VERTICAL. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157252 BI-METRIC/X POR COLLAR 13X145 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 750440

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R