BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT CEMENTLESS SIZE 7.5 STAND

    MDR report key: 8625621 · Received May 20, 2019

    Report

    Report Number
    0001822565-2019-02136
    Event Type
    Injury
    Date Received
    May 20, 2019
    Report Date
    June 10, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K953337
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D11: FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER, 00801803203, LN 61661894 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. MDR: 0002648920-2019-00424, 0001822565-2019-02137-1 AND 0001822565-2019-02138-1. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    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: UNKNOWN HEAD, PN UNKNOWN, LN UNKNOWN; UNKNOWN CUP, PN UNKNOWN, LN UNKNOWN; UNKNOWN LINER, PN UNKNOWN, LN UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2019-02118; 0001822565-2019-02137; 0001822565-2019-02138. 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
    419416 FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT CEMENTLESS SIZE 7.5 STAND PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 61679363

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R