BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER BIOLOXD OPTION HD 32MM

    MDR report key: 7610053 · Received June 18, 2018

    Report

    Report Number
    0001825034-2018-04069
    Event Type
    Injury
    Date Received
    June 18, 2018
    Date of Event
    December 5, 2012
    Report Date
    September 24, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    PK082996
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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 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, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: ITEM # XL-105933, LINER, LOT # 819390, ITEM # 31-323230, DRILL BIT, LOT # 468210, ITEM # 650-1066, TAPER SLEEVE, LOT # 623600, ITEM # 103531, BONE SCREW, LOT # 268940, ITEM # 103530, BONE SCREW, LOT # 879960, ITEM # 103530, BONE SCREW, LOT # 322800, ITEM # 16-104150, CUP, LOT # 263080, ITEM # 150457, PROXIMAL FEMORAL, LOT # 915480. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-04068, 0001825034-2018-04069.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY 5 MONTHS POST IMPLANTATION DUE TO DISLOCATION, IN WHICH THE FEMORAL HEAD AND LINER WERE REVISED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452357 CER BIOLOXD OPTION HD 32MM HIP PROSTHESIS LZO ZIMMER BIOMET, INC. N/A 854050 

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R