BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA CERAMIC HEAD

    MDR report key: 8089637 · Received November 20, 2018

    Report

    Report Number
    0001825034-2018-10807
    Event Type
    Injury
    Date Received
    November 20, 2018
    Date of Event
    January 13, 2016
    Report Date
    August 1, 2019
    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
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES NOTING AN INFECTION OF THE HIP. IRRIGATION AND DEBRIDEMENT OF THE LEFT TOTAL HIP ARTHROPLASTY. THE HEAD AND LINER COMPONENTS WERE EXCHANGED AND ANTIBIOTIC-IMPREGNATED BEADS WERE PLACED. 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 ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 650-1067 ¿ BIOLOX DELTA CERAMIC TAPER ¿ 617610, EP-200156 ¿ ACTIVE ARTICULATION HIP BRG - 274460, X181314 ¿ BI-METRIC FEMORAL STEM ¿ 306760, US157856 ¿ M2A MAGNUM CUP ¿ 914110, THERAPY DATE: UNKNOWN. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 10806, 0001825034 - 2018 - 10810.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TWO-STAGE REVISION ON THE LEFT HIP APPROXIMATELY 5 MONTHS POST FIRST REVISION SURGERY DUE TO INFECTION. PATIENT WAS THEN REIMPLANTED WITH PERMANENT DEVICES APPROXIMATELY 4 MONTHS LATER. 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
    928831 BIOLOX DELTA CERAMIC HEAD PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 027320

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R