BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPRLC 133 T1 PPS HO 16X152MM

    MDR report key: 8678937 · Received June 7, 2019

    Report

    Report Number
    0001825034-2019-02469
    Event Type
    Malfunction
    Date Received
    June 7, 2019
    Report Date
    January 13, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWY
    PMA / PMN Number
    K101086
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 MDR'S WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORT(S): 0001825034 - 2019 - 02469, 0001825034 - 2019 - 02470, 0001825034 - 2019 - 02471, 0001825034 - 2019 - 02472, 0001825034 - 2019 - 02473, 0001825034 - 2019 - 02474, 0001825034 - 2019 - 02475, 0001825034 - 2019 - 02476, 0001825034 - 2019 - 02477, 0001825034 - 2019 - 02479, 0001825034 - 2019 - 02480, 0001825034 - 2019 - 02481, 0001825034 - 2019 - 02482, 0001825034 - 2019 - 02483, 0001825034 - 2019 - 02484, 0001825034 - 2019 - 02485, 0001825034 - 2019 - 02486, 0001825034 - 2019 - 02487. CONCOMITANT MEDICAL PRODUCTS: ITEM # ITEM NAME LOT NUMBER PRIMARY DI# 51-104160 TPRLC 133 T1 PPS HO 16X152MM 3817553 00880304491854,  51-104160 TPRLC 133 T1 PPS HO 16X152MM 6028661 00880304491854 , 51-104140 TPRLC 133 T1 PPS HO 14X148MM 3817531 00880304491847,  51-103180 TPRLC 133 T1 PPS SO 18X156MM 3975978 00880304498358,  51-103180 TPRLC 133 T1 PPS SO 18X156MM 6022911 00880304498358,  51-103170 TPRLC 133 T1 PPS SO 17X154MM 6238743 00880304498341,  51-103170 TPRLC 133 T1 PPS SO 17X154MM 6133628 00880304498341,  51-103160 TPRLC 133 T1 PPS SO 16X152MM 6309256 00880304489691,  51-103150 TPRLC 133 T1 PPS SO 15X150MM 6118653 00880304491861,  51-103140 TPRLC 133 T1 PPS SO 14X148MM 6075801 00880304491816,  51-103140 TPRLC 133 T1 PPS SO 14X148MM 6170567 00880304491816,  51-103130 TPRLC 133 T1 PPS SO 13X146MMTP 6308779 00880304489677,  51-103090 TPRLC 133 TYPE1 PPS SO 9X137MM 6462370 00880304498334,  51-100080 TPRLC 133 FP TYPE1 PPS SO 8.0 6364712 00-88030489660, 51-100060 TPRLC 133 FP TYPE1 PPS SO 6.0 6289409 00880304498174,  51-100060 TPRLC 133 FP TYPE1 PPS SO 6.0 6273744 00880304498174,  51-100050 TPRLC 133 FP TYPE1 PPS SO 5.0 6241443 00880304498167,  51-100040 TPRLC 133 FP TYPE1 PPS SO 4.0 6246127 NOT RELEASED. 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 THE DEVICE PACKAGING HAD DAMAGE THAT COMPROMISED STERILITY. NO PATIENT OR SURGICAL INVOLVEMENT AS THE ISSUE WAS IDENTIFIED IN THE INVENTORY WAREHOUSE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474227 TPRLC 133 T1 PPS HO 16X152MM PROSTHESIS, HIP KWY ZIMMER BIOMET, INC. N/A 3817553

    Patients

    Seq Age Sex Outcome Treatment
    1 SEE H10