BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BI-MET CO-CR HD/NK 13X34X250 R

    MDR report key: 9217753 · Received October 22, 2019

    Report

    Report Number
    0001825034-2019-04768
    Event Type
    Malfunction
    Date Received
    October 22, 2019
    Report Date
    October 21, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00880304223080
    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 · 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 - 04773, 0001825034 - 2019 - 04771, 0001825034 - 2019 - 04766, 0001825034 - 2019 - 04767, 0001825034 - 2019 - 04772, 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
    1012236 BI-MET CO-CR HD/NK 13X34X250 R PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 413690 00880304223080

    Patients

    Seq Age Sex Outcome Treatment
    1