BEUDAMED
    FDA Adverse Event Injury Summary report: N

    -----

    MDR report key: 7763292 · Received August 8, 2018

    Report

    Report Number
    0001825034-2018-06984
    Event Type
    Injury
    Date Received
    August 8, 2018
    Date of Event
    February 12, 2015
    Report Date
    September 21, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ASSOCIATED ITEM NUMBER 010000662, ITEM NAME G7 PPS LTD ACET SHELL 50D, LOT # 3423437; ASSOCIATED ITEM NUMBER 010000848, ITEM NAME G7 NEUTRAL E1 LINER 32MM D, LOT # 3309813; ASSOCIATED ITEM NUMBER 650-1065, ITEM NAME CER OPTION TYPE 1 TPR SLEVE -3, LOT # 904030. REPORTED EVENT WAS CONFIRMED DUE TO REVIEW OF PROVIDED MEDICAL RECORDS AND/OR PATIENT X-RAYS. DHR WAS REVIEWED AND NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ITEM AND LOT NUMBER OF IMPLANT IN THIS EVENT ARE UNKNOWN. ITEM, LOT NUMBER, MANUFACTURING DATE AND EXPIRY DATE AND 510K DETAILS REPORTED IN THE INITIAL MDR ARE NOT RELATED TO THIS EVENT. REPORTED EVENT WAS CONFIRMED BY REVIEW OF REVISION OP NOTES. 2 WEEKS S/P PATIENT PRESENTED WITH DISTAL PERIPROSTHETIC FRACTURE OF THE TIP OF THE STEM. THE STEM FROM THE PREVIOUS REVISION APPEARED TO BE WELL FIXED AND WELL POSITIONED. REVISION ARTHROPLASTY PERFORMED WITH CABLE FIXATION, REVISION STEM AND HEAD/NECK, WITH PLACEMENT OF ANTIBIOTIC BEADS FOR PROPHYLAXIS. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 · 1

    IT WAS REPORTED THE PATIENT WAS RE-REVISED DUE TO RECURRENT PERIPROSTHETIC FRACTURE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603542 ----- PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 3311813

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R