BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER OPTION TYPE 1 TPR SLEVE +3

    MDR report key: 8164494 · Received December 14, 2018

    Report

    Report Number
    0001825034-2018-11272
    Event Type
    Injury
    Date Received
    December 14, 2018
    Date of Event
    May 20, 2018
    Report Date
    December 12, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    K082996
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UNIQUE IDENTIFIER (UDI) #: N/A. CONCOMITANT MEDICAL PRODUCTS: 010000665, G7 PPS LTD ACET SHELL 56F, 6229129; 010000858, G7 NEUTRAL E1 LINER 36MM F, 6237888; 193011, ECHO B-MTRC MP FP SO 11, 551060; 650-1057, CER BIOLOXD OPTION HD 36MM, 2907284. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS WHICH STATE THAT THE PATIENT UNDERWENT EXPLANT OF THE TOTAL HIP WITH PLACEMENT OF AN ANTIBIOTIC-COATED ARTICULATING SPACER DUE TO INFECTION. ESTIMATED BLOOD LOSS 800ML AND PACKED RED BLOOD CELL TRANSFUSION. RETURNED COMPONENTS WERE EVALUATED AND FOUND CONFORMING TO PRINT SPECIFICATIONS. DEVICE HISTORY RECORD 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 · 1

    IT WAS REPORTED PATIENT UNDERWENT AN INITIAL LEFT HIP PROCEDURE. PATIENT THEN REPORTED AN ACUTE ONSET OF PROGRESSIVE PAIN AND SWELLING FOR 6 DAYS FOLLOWING A GASTROINTESTINAL ILLNESS APPROXIMATELY A MONTH AND A HALF POST SURGERY. SUBSEQUENTLY, PATIENT UNDERWENT A HIP REVISION SURGERY DUE TO PAIN, SWELLING, AND INFECTION LESS THAN 2 MONTHS POST IMPLANTATION. DURING THE REVISION PROCEDURE, THE PATIENT EXPERIENCED AN ESTIMATED BLOOD LOSS OF 800 MLS AND REQUIRED A PACKED RED BLOOD CELL TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1004926 CER OPTION TYPE 1 TPR SLEVE +3 HIP PROSTHESIS LZO ZIMMER BIOMET, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other