BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERAMIC BIOLOXD OPTION HEAD 36MM

    MDR report key: 7439278 · Received April 18, 2018

    Report

    Report Number
    0001825034-2018-02529
    Event Type
    Injury
    Date Received
    April 18, 2018
    Date of Event
    March 26, 2018
    Report Date
    May 8, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. 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). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO HOSPITAL REGULATIONS. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT PRODUCT(S): BIOMET G7 NEUTRAL E1 LINER 36MM F ITEM#: 010000858, LOT#: 3959798; BIOMET CER OPT TYPE 1 TPR SLEVE 0MM ITEM#: 650-1066, LOT#: 2904624; BIOMET G7 PPS LTD ACET SHELL 56F ITEM#: 010000665, LOT#: 6209980; BIOMET ARCOS CON SZ C STD 60MM, ITEM#: 11-301303, LOT#: 795060; BIOMET ARCOS 19X115MM CYL DIST ITEM#: 11-301419. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 02526, 0001825034 - 2018 - 02530.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY 4 WEEKS POST-IMPLANTATION DUE TO INFECTION. PATIENT RECEIVED AN IRRIGATION AND DEBRIDEMENT WITH A HEAD AND LINER REPLACEMENT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284173 CERAMIC BIOLOXD OPTION HEAD 36MM HIP PROSTHESIS LZO ZIMMER BIOMET, INC. N/A 2887373

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R