BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 CURVED INSERTER THD SHAFT

    MDR report key: 16094522 · Received January 4, 2023

    Report

    Report Number
    0001825034-2023-00015
    Event Type
    Malfunction
    Date Received
    January 4, 2023
    Date of Event
    December 9, 2022
    Report Date
    January 27, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    UDI-DI
    00880304543331
    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). 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 - 2022 - 02865 THE CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED SCRATCHES ON THE SHAFTS OF BOTH INSERTERS. THE HEX FEATURES ARE NICKED AND SCRATCHED. NO THREAD DAMAGE WAS OBSERVED ON EITHER INSERTER. MEDICAL RECORDS WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. 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.

    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. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1199423 G7 CURVED INSERTER THD SHAFT INSTURMENT, HIP PBI ZIMMER BIOMET, INC. N/A 073895 00880304543331

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown