BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALANCE MICROP STEM 17X80MM LT

    MDR report key: 9217735 · Received October 22, 2019

    Report

    Report Number
    0001825034-2019-04767
    Event Type
    Malfunction
    Date Received
    October 22, 2019
    Report Date
    January 7, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    UDI-DI
    00880304455375
    PMA / PMN Number
    K050251
    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, 0001825034-2019-04773, 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
    1012006 BALANCE MICROP STEM 17X80MM LT PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 193920 00880304455375

    Patients

    Seq Age Sex Outcome Treatment
    1 SEE H10