BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIV 2-HOLE SHL 56MM LNR SZ 24

    MDR report key: 8834737 · Received July 28, 2019

    Report

    Report Number
    0001825034-2019-03262
    Event Type
    Injury
    Date Received
    July 28, 2019
    Date of Event
    August 13, 2016
    Report Date
    November 19, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    K030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PATIENT INFORMATION: DATE OF BIRTH- UNKNOWN MONTH AND DAY IN 1969. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (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 FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: EPOLY 36MM RLC LNR MROM SZ24, PN EP-105994, LN 882430, TPRLC 133 MP TYPE1 PPS SO 12.0, PN 51-106120, LN 3455265, DELTA CERAMIC FEM HD 36/-3MM, PN 650-0660, LN 2015080065. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS 0001825034-2019-03263, 0001825034-2019-03264, 0001825034-2019-03265. REPORT SOURCE: (B)(6). 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 A PATIENT HAS EXPERIENCED DEEP INFECTION APPROXIMATELY 3 MONTHS AFTER THE INITIAL SURGERY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628517 UNIV 2-HOLE SHL 56MM LNR SZ 24 PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 619240

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other