BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER OPTION TYPE 1 TPR SLEVE +3

    MDR report key: 8296356 · Received February 1, 2019

    Report

    Report Number
    0001825034-2019-00363
    Event Type
    Injury
    Date Received
    February 1, 2019
    Date of Event
    November 2, 2018
    Report Date
    April 10, 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
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 110010571 ¿ G7 SUCTION CUP ¿ 791290; 11-300920 ¿ ARCOS DISTAL STEM ¿ 011130; 11-301300 ¿ ARCOS CONE BODY - 494970; XL-200152 ¿ BEARING ¿ 438540; 650-1055 ¿ BIOLOXD HEAD ¿ 2907257; 00500106028 ¿ LINER ¿ 62549488; 00500106000 ¿ SHELL - 37212712. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT WAS DISCARDED. 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: 0001825034-2019-00360, 0001825034-2018-10888, 0001825034-2018-10889, 0001825034-2018-10890.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 7 MONTHS POST IMPLANTATION DUE TO DISLOCATION AND INFECTION. DURING THE SURGERY, ALL IMPLANTS WERE REMOVED AND REPLACED. 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
    90505 CER OPTION TYPE 1 TPR SLEVE +3 PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 2934995

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R