BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER

    MDR report key: 8716195 · Received June 20, 2019

    Report

    Report Number
    0002648920-2019-00424
    Event Type
    Injury
    Date Received
    June 20, 2019
    Report Date
    June 12, 2019
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JDI
    PMA / PMN Number
    K953337
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT CEMENTLESS SIZE 7.5 STANDARD. OFFSET REDUCED NECK LENGTH, PN 00771100710, LN 61679363. SHELL POROUS WITH CLUSTER HOLES 50 MM, PN 00620205022, LN 61753554. LINER 10 DEGREE ELEVATED RIM 32 MM I.D. FOR USE WITH 50/52/54 MM O.D. SHELLS, PN 00631005032, LN 61639292. BONE SCR 6.5X30 SELF-TAP, PN 00625006530, LN 61639292. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS 0001822565-2019-02136-1, 0001822565-2019-02137-1, 0001822565-2019-02138-1. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PATIENT¿S LEGAL COUNSEL REPORTED PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, PATIENT EXPERIENCED AN UNSPECIFIED COMPLICATION; HOWEVER, NO REVISION HAS BEEN REPORTED AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513135 FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER PROSTHESIS, HIP JDI ZIMMER MANUFACTURING B.V. N/A 61661894

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R