BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM COCR MOD HD +6MM NO SKIRT

    MDR report key: 7999146 · Received October 24, 2018

    Report

    Report Number
    0001825034-2018-09873
    Event Type
    Injury
    Date Received
    October 24, 2018
    Date of Event
    August 31, 2004
    Report Date
    March 21, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K974558
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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 · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 162613 ¿ POROUS INTEGRAL HIP ¿ 860250. 11-165226 ¿ RINGLOC BI POLAR ¿ 442050. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. 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 RIGHT HIP REVISION APPROXIMATELY 4 YEARS POST IMPLANTATION DUE TO PAIN AND LIMB LENGTH DISCREPANCY. 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
    842843 28MM COCR MOD HD +6MM NO SKIRT PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 437070

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R