BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPT FEMORAL STEM

    MDR report key: 8018341 · Received October 30, 2018

    Report

    Report Number
    0002648920-2018-00779
    Event Type
    Injury
    Date Received
    October 30, 2018
    Date of Event
    October 29, 2014
    Report Date
    February 26, 2019
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JDI
    PMA / PMN Number
    K960658
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THIS MDR SHOULD NOT HAVE BEEN FILED AS THE COMPLAINT IS A DUPLICATED AND WAS PREVIOUSLY REPORTED ON 0002648920-2017-00582.

    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: 00801802803 FEMORAL HEAD 62549102, RM40901 000 2 COMPETITOR CUP 1310303A, RM 5110 003 2 COMPETITOR LINER 1311334A, 00801102016 ALLEN PLUG 62248693. EVENT REPORTED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS LOCATION IS UNKNOWN. 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 HAD UNDERWENT A HIP ARTHROPLASTY, SUBSEQUENTLY WAS REVISED APPROXIMATELY 7 MONTHS POST OPERATIVELY DUE TO A PERIPROSTHETIC FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860999 CPT FEMORAL STEM PROSTHESIS, HIP JDI ZIMMER MANUFACTURING B.V. N/A 62588002

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R