BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 PPS LTD ACET SHELL 52E

    MDR report key: 16265262 · Received January 30, 2023

    Report

    Report Number
    0001825034-2023-00155
    Event Type
    Malfunction
    Date Received
    January 30, 2023
    Date of Event
    December 9, 2022
    Report Date
    January 25, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    UDI-DI
    00880304524224
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CAT#: 51-104130, LOT: 7120334 TPRLC 133 T1 PPS, CAT#: 010000663, LOT: 7330092 G7 PPS LTD ACET SHELL, CAT#: 30123605, LOT: 65588031 7 VIT E HIGH WALL LNR, CAT#: 650-1068, LOT: 3063671 CER OPTION TYPE 1 TPR SLEVE, CAT#: 650-1057, LOT: 3127943 CER BIOLOXD OPTION, CAT#: 00-6250-065-30, LOT: J7375801 BONE SCREW 6.5X30, CAT#: 31-323220, LOT: 65717604 3.2MMX20MM RNGLC+ ACET DRL BIT. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2023-00015, 0001825034-2022-02865. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. MEDICAL RECORDS WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE THREADED SHAFT IS COMING LOOSE FROM THE CUP. THERE WAS NO CONSEQUENCES OR IMPACT TO THE PATIENT. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15964 G7 PPS LTD ACET SHELL 52E PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 7330092 00880304524224

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown