BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 HI-WALL ARCOMXL LNR 36MM F

    MDR report key: 19032667 · Received April 3, 2024

    Report

    Report Number
    0001825034-2024-00927
    Event Type
    Malfunction
    Date Received
    April 3, 2024
    Date of Event
    March 13, 2024
    Report Date
    August 14, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    UDI-DI
    00880304526020
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 650-1162 DELTA CER FEM HD 32/0MM T1 3161013. 110017105 G7 FINNED 4 HOLE SHELL 56F 7549003. G2: FOREIGN: MEXICO. 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 AND/OR CORRECTED INFORMATION. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE COMPLAINT CANNOT BE CONFIRMED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INITIAL HIP ARTHROPLASTY THAT THE INSERT WAS IMPACTED SEVERAL TIMES WHILE TRYING TO INSERT AND AFTER APPROXIMATELY FORTY (40) MINUTES THE LINER WAS UNABLE TO BE INSERTED. THE PATIENT BEGAN TO BLEED, AND THE SURGEON DECIDED TO OPEN ANOTHER INSERT AND ANOTHER FEMORAL HEAD IN THE NEXT DIAMETER, BEING THE OPTION THAT WAS AVAILABLE AT THE TIME. THE CUP WAS SUCCESSFULLY IMPLANTED WITHOUT ANY PROBLEMS. SURGICAL TECHNIQUE OF THE PRODUCTS WAS UTILIZED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1689376 G7 HI-WALL ARCOMXL LNR 36MM F PROSTHESIS, HIPS PBI ZIMMER BIOMET, INC. N/A 6913062 00880304526020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H10 NARRATIVE.