BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPRLC 133 T1 PPS HO 16X152MM

    MDR report key: 8678941 · Received June 7, 2019

    Report

    Report Number
    0001825034-2019-02470
    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, 0001825034-2019-02471, 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. ASSOCIATED DEVICE(S): ITEM #: 51-104160, ITEM NAME: TPRLC 133 T1 PPS HO 16X152MM, LOT NUMBER: 3817553, PRIMARY DI#: (B)(4); 51-104160, TPRLC 133 T1 PPS HO 16X152MM, 6028661, (B)(4); 51-104140, TPRLC 133 T1 PPS HO 14X148MM, 3817531, (B)(4); 51-103180, TPRLC 133 T1 PPS SO 18X156MM, 3975978, (B)(4); 51-103180, TPRLC 133 T1 PPS SO 18X156MM, 6022911, (B)(4); 51-103170,TPRLC 133 T1 PPS SO 17X154MM, 6238743, (B)(4); 51-103170, TPRLC 133 T1 PPS SO 17X154MM, 6133628, (B)(4); 51-103160, TPRLC 133 T1 PPS SO 16X152MM, 6309256, (B)(4); 51-103150, TPRLC 133 T1 PPS SO 15X150MM, 6118653, (B)(4); 51-103140, TPRLC 133 T1 PPS SO 14X148MM, 6075801, (B)(4); 51-103140, TPRLC 133 T1 PPS SO 14X148MM, 6170567, (B)(4); 51-103130, TPRLC 133 T1 PPS SO 13X146MMTP, 6308779, (B)(4); 51-103090, TPRLC 133 TYPE1 PPS SO 9X137MM, 6462370, (B)(4); 51-100080, TPRLC 133 FP TYPE1 PPS SO 8.0, 6364712, (B)(4); 51-100060, TPRLC 133 FP TYPE1 PPS SO 6.0, 6289409, (B)(4); 51-100060, TPRLC 133 FP TYPE1 PPS SO 6.0, 6273744, (B)(4); 51-100050, TPRLC 133 FP TYPE1 PPS SO 5.0, 6241443, (B)(4); 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
    470941 TPRLC 133 T1 PPS HO 16X152MM PROSTHESIS, HIP KWY ZIMMER BIOMET, INC. 6028661

    Patients

    Seq Age Sex Outcome Treatment
    1