BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M/H SLD/APX HLE RNGLC SHL 50MM

    MDR report key: 7759391 · Received August 7, 2018

    Report

    Report Number
    0001825034-2018-05809
    Event Type
    Injury
    Date Received
    August 7, 2018
    Date of Event
    March 19, 2014
    Report Date
    October 17, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    PK921181
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MEDICAL DEVICES: ITEM # 51-107100, STEM, LOT # 2811558, ITEM # 650-1056, HEAD, LOT # 302990, ITEM # EP-105933, LINER, LOT # 590610, ITEM # 650-1065, TAPER SLEVE, LOT # 190990. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 05807, 0001825034 - 2018 - 05808, 0001825034 - 2018 - 05810, 0001825034 - 2018 - 05811.

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, THIS REPORT SHOULD BE VOIDED AS IT WAS DETERMINED TO BE A DUPLICATE OF MFR NUMBER 0001825034-2014-04621.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 1 YEAR POST IMPLANTATION, THE PATIENT WAS NOTED TO HAVE CONTINUED COMPLAINTS OF PAIN AND WAS FOUND TO HAVE A (B)(6) INFECTION. THE PATIENT SUBSEQUENTLY UNDERWENT A TWO-STAGE REVISION, WITH ANTIBIOTIC SPACERS PLACED DURING THIS EVENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598352 M/H SLD/APX HLE RNGLC SHL 50MM PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 300900

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R