BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPRLC 133 MP TYPE1 PPS SO 12.0

    MDR report key: 15958800 · Received December 12, 2022

    Report

    Report Number
    0001825034-2022-02771
    Event Type
    Malfunction
    Date Received
    December 12, 2022
    Date of Event
    November 16, 2022
    Report Date
    December 15, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    UDI-DI
    00880304514317
    PMA / PMN Number
    K110400
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: H2; H3; H6 COMPONENT CODE: MECHANICAL (G04) ¿ STEM NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR DEVIATIONS AND/OR ANOMALIES WITH THE FOLLOWING RELATED ANOMALIES/DEVIATIONS IDENTIFIED: THE AUTO BLASTER WAS DOWN SO THEY HAD TO USE A MANUAL BLASTER, HOWEVER, THE DEVICE INSPECTION SHOWED THE DEVICE WAS CONFORMING PER SPEC. THEREFORE, IT IS UNLIKELY THAT THE DEVIATION CONTRIBUTED 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. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CAT#: 31-323220/ 3.2MMX20MM RNGLC+ ACET DRL BIT/LOT#: 546040. CAT#: 110010244/ G7 OSSEOTI 3 HOLE SHELL 52MM E/ LOT#: 65459659. CAT#: 30103605/ G7 VIT E NEUTRAL LNR 36MM E/LOT #: 65560835. CAT#: 00-6250-065-20/ BONE SCREW 6.5X20 SELFTAP/ LOT#: J7238089. CAT#: 00-6250-065-20/ BONE SCREW 6.5X20 SELFTAP/ LOT#: J7348330. CAT#: 51-106120/ TPRLC 133 MP TYPE1 PPS SO 12.0/LOT#: 7041275. CAT#: 650-0661/ DELTA CERAMIC FEM HD 36/0MM/LOT#: 3119037. CAT#: 98-0001-000-37/ PR PRM ST/OSS LH CP/VE LN/CER/INS. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, AS SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE INSERTING THE STEM, THE DOCTOR NOTED THAT IT LOOKED LIKE THE GRIT BLAST WAS COMING OFF THE STEM. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2181603 TPRLC 133 MP TYPE1 PPS SO 12.0 PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. NI 7041275 00880304514317

    Patients

    Seq Age Sex Outcome Treatment
    1 Male