BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS POROUS IM STEM 14.5 X 150

    MDR report key: 11327265 · Received February 15, 2021

    Report

    Report Number
    0001825034-2021-00466
    Event Type
    Injury
    Date Received
    February 15, 2021
    Date of Event
    January 4, 2019
    Report Date
    June 29, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K123501
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: B4, B5, G3, H2, H3, H6 . REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. MEDICAL RECORDS IDENTIFIED THE FOLLOWING: ATTEMPTED TO DISENGAGE THE INTERCALARY SEGMENT FROM DISTAL FEMORAL COMPONENT, WAS COLD WELDED, DURING ATTEMPT TO REMOVE, A FRACTURE OCCURRED DISTAL TO WELL-FIXED STEM, RESULTING IN REMOVAL OF STEM. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT 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 DEVICES: 650-1055 BOLOLXD HEAD 428120; 650-1066 SLEVE TAPER 779450; 150458 OSS BODY 231590; 87-3435 DEPUY LINER 7930873; ITEM #: UNKNOWN, UNKNOWN COMPETITOR CUP LOT #: UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE PRODUCT LOCATION IS UNKNOWN. 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 - 2021 - 00467.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT THA ON AN UNKNOWN DATE. THE PATIENT WAS REVISED SEVERAL TIMES. DURING THE LATEST PROCEDURE, IT WAS FOUND THAT THE BODY WAS COLD WELDED TO THE DISTAL STEM. IN THE ATTEMPT TO DISENGAGE THE BODY FROM THE STEM, THE STEM WAS ALSO FRACTURED AND HAD TO BE REPLACED. LEG LENGTH WAS ADDRESSED WITH THE NEW STEM AND THE FEMUR WAS CABLED TO AVOID FRACTURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226458 OSS POROUS IM STEM 14.5 X 150 PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 249710

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention SEE H10