BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XLPE LINER

    MDR report key: 10249876 · Received July 9, 2020

    Report

    Report Number
    0001822565-2020-02469
    Event Type
    Injury
    Date Received
    July 9, 2020
    Date of Event
    June 9, 2020
    Report Date
    October 8, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K990135
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION PROVIDED BY THE CUSTOMER. REVIEW OF PHOTOGRAPHS SHOWS THE RIM OF THE LINER TO BE FRACTURED, WHICH MOST LIKELY OCCURRED DURING REMOVAL AS THERE WERE NO ALLEGATIONS CLAIMING IN-VIVO FRACTURE. DHR WAS REVIEWED AND NO DISCREPANCIES THAT WOULD ATTRIBUTE TO THE REPORTED EVENT WERE FOUND. THE ROOT CAUSE IS 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 650-1055 ¿ BIOLOX HEAD ¿ 080530; 650-1068 ¿ BIOLOX TAPER ¿ 092440; UNKNOWN STEM ¿ UNKNOWN PART AND LOT; UNKNOWN CUP ¿ UNKNOWN PART AND LOT. REPORT SOURCE - (B)(6). PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR THE INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 7 YEARS POST IMPLANTATION DUE TO DISLOCATION. 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
    712946 XLPE LINER PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 62257386

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R