BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHELL POROUS WITH CLUSTER HOLES 50 MM

    MDR report key: 8625636 · Received May 20, 2019

    Report

    Report Number
    0001822565-2019-02137
    Event Type
    Injury
    Date Received
    May 20, 2019
    Report Date
    June 10, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K021891
    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). FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER, 00801803203, LN 61661894 FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT CEMENTLESS SIZE 7.5 STANDARD OFFSET REDUCED NECK LENGTH, PN 00771100710, LN 61679363 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. 0001822565-2019-02136-1. 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 STEM, 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
    416245 SHELL POROUS WITH CLUSTER HOLES 50 MM PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 61753554

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R