BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX OPTION TAPER ADAPTER STD NECK

    MDR report key: 7769090 · Received August 9, 2018

    Report

    Report Number
    0001825034-2018-07912
    Event Type
    Injury
    Date Received
    August 9, 2018
    Date of Event
    August 28, 2014
    Report Date
    October 10, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    PK082996
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UNKNOWN TM SHELL: UNKNOWN PART AND LOT. UNKNOWN TRILOGY LINER: UNKNOWN PART AND LOT. 650-1057: BIOLOX CERAMIC HEAD: 540320. 51-149050: TAPERLOC FEMORAL STEM: 2931611. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. CULTURES WERE SAID TO HAVE REVEALED THE GROWTH OF MRSA, HOWEVER RESULTS WERE NOT PROVIDED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM # UNK, CUP, LOT # UNK; ITEM # UNK, LINER, LOT # UNK; ITEM # 650-1057, HEAD, LOT # UNK; ITEM # 51-149050, STEM, LOT # UNK. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION DUE TO PAIN AND INSTABILITY APPROXIMATELY TEN MONTHS LATER. ONE MONTH FOLLOWING THE REVISION PROCEDURE, THE PATIENT DEVELOPED AN INFECTION AT THE SURGICAL SITE. THE PATIENT WAS TREATED WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611431 BIOLOX OPTION TAPER ADAPTER STD NECK PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 001110

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention