BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER BIOLOXD OPTION HD 28MM

    MDR report key: 7768679 · Received August 9, 2018

    Report

    Report Number
    0001825034-2018-07871
    Event Type
    Injury
    Date Received
    August 9, 2018
    Date of Event
    July 12, 2017
    Report Date
    October 16, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    PK082996
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED PRODUCT TO BE RELATED HOWEVER TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    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 # UNK, STEM, LOT # UNK, ITEM # EP-200152, SHELL, LOT # 902290, ITEM # 110024465, LINER, LOT # 642280, ITEM # 650-1067, TAPER SLEVE, LOT # 2887431. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 07870, 0001825034 - 2018 - 07872, 0001825034 - 2018 - 07873.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 2 MONTHS POST IMPLANTATION/REVISION, THE PATIENT WAS REVISED AGAIN DUE TO INSTABILITY AND FAILED ABDUCTOR REPAIR. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610645 CER BIOLOXD OPTION HD 28MM PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 2887342

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R