BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BI-MET CO-CR HD/NK 13X45X200

    MDR report key: 9217759 · Received October 22, 2019

    Report

    Report Number
    0001825034-2019-04773
    Event Type
    Malfunction
    Date Received
    October 22, 2019
    Report Date
    January 7, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00880304222908
    PMA / PMN Number
    K992058
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS DETERMINED THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO A REPORTABLE MALFUNCTION, SERIOUS INJURY, OR ADVERSE EVENT. PLEASE VOID THIS SUBMISSION.

    Description of Event or Problem · 0

    IT WAS DETERMINED THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO A REPORTABLE MALFUNCTION, SERIOUS INJURY, OR ADVERSE EVENT. PLEASE VOID THIS SUBMISSION.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDRS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED: 0001825034 - 2019 - 04760, 0001825034 - 2019 - 04761, 0001825034 - 2019 - 04762, 0001825034 - 2019 - 04778, 0001825034 - 2019 - 04770, 0001825034 - 2019 - 04776, 0001825034 - 2019 - 04763, 0001825034 - 2019 - 04764, 0001825034 - 2019 - 04771, 0001825034 - 2019 - 04766, 0001825034 - 2019 - 04767, 0001825034 - 2019 - 04772, 0001825034 - 2019 - 04768, 0001825034 - 2019 - 04774, 0001825034 - 2019 - 04775. CONCOMITANT MEDICAL PRODUCTS: 11-162115, REACH, 15X250, LT, 100%, POR, FMRL, 251140. 11-104955, MLRY-HD, CAL, W/HOLE, 34X17X220, R, 275470R. 12-162584 , BI-MET, CO-CR, HD/NK, 13X34X250, R, 413690. 12-162485, BI-MET, CO-CR, HD/NK, 13X45X200, 682040. 12-162484, BI-MET, CO-CR, HD/NK, 11X45X200, 179580. 11-162117, REACH, 17X250, LT, 100%, POR, FMRL, 441120. 12-162596, BI-MET, CO-CR, HD/NK, 13X55X250, R, 808630. 12-162485, BI-MET, CO-CR, HD/NK, 13X45X200, 703910. 12-162574, BI-MET, CO-CR, HD/NK, 15X34X250, R, 046710. 12-162588, BI-MET, CO-CR, HD/NK, 11X45X250, R, 821500. 12-162489, BI-MET, CO-CR, HD/NK, 15X34X200, 627880. 12-162490, BI-MET, CO-CR, HD/NK, 15X45X200, 307010. 180221, BALANCE, MICROP, STEM, 17X80MM, LT, 193920. 12-162485, BI-MET, CO-CR, HD/NK, 13X45X200, 314510. 11-104973, MLRY-HD, CAL, W/HOLE, 45X17X220, R, 066930. 12-162481, BI-MET, CO-CR, HD/NK, 11X34X200, 009370. 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 DURING THE DISTRIBUTION PROCESS PACKAGING DAMAGE WITH STERILITY BARRIER POTENTIALLY COMPROMISED WAS IDENTIFIED. NO PATIENT OR SURGICAL INVOLVEMENT. NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1012239 BI-MET CO-CR HD/NK 13X45X200 PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 314510 00880304222908

    Patients

    Seq Age Sex Outcome Treatment
    1