BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BI-MET CO-CR HD/NK 15X45X200

    MDR report key: 9217716 · Received October 22, 2019

    Report

    Report Number
    0001825034-2019-04763
    Event Type
    Malfunction
    Date Received
    October 22, 2019
    Report Date
    January 7, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00880304222960
    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 - 04764. 0001825034 - 2019 - 04773. 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
    1014340 BI-MET CO-CR HD/NK 15X45X200 PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 307010 00880304222960

    Patients

    Seq Age Sex Outcome Treatment
    1