BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 OSSEOTI 4 HOLE SHELL 54MM F

    MDR report key: 16247128 · Received January 26, 2023

    Report

    Report Number
    0001825034-2023-00165
    Event Type
    Malfunction
    Date Received
    January 26, 2023
    Date of Event
    January 3, 2023
    Report Date
    March 9, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00880304544208
    PMA / PMN Number
    K140669
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CMP: (B)(4). CONCOMITANT MEDICAL PRODUCTS: 30103606 G7 VIT E NEUTRAL LNR 36MM F 65627121. 650-1064 CER OPTION TYPE 1 TPR SLEVE -6 3131015. 650-1057 CER BIOLOXD OPTION HD 36MM 3128053. 51-103130 TPRLC 133 T1 PPS SO 13X146MMTP 7156585. 00-6250-065-20 BONE SCREW 6.5X20 SELFTAP 65438667. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    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. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS/THESE ITEM(S) AND THE REPORTED PART AND LOT COMBINATION(S). MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 THE CUP WAS IMPACTED INTO THE PATIENT. THE CUP SEEMED TO HAVE GOOD PURCHASE AND BE SOLID. AFTER TRIALING, THE HEAD AND LINER FROM THE BROACH, THE CUP WAS LOOSE. NOT RELATED TO THE QUALITY OF THE REAMING AND ACETABULUM. SCREWS WERE INSERTED. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792711 G7 OSSEOTI 4 HOLE SHELL 54MM F PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 65416419 00880304544208

    Patients

    Seq Age Sex Outcome Treatment
    1 Female