BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 NEUTRAL E1 LINER 40MM F

    MDR report key: 7572219 · Received June 5, 2018

    Report

    Report Number
    0001825034-2018-03584
    Event Type
    Malfunction
    Date Received
    June 5, 2018
    Date of Event
    May 14, 2018
    Report Date
    December 13, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    PK121874
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. UPON VISUAL INSPECTION THERE IS DAMAGE TO THE SCALLOPS SHOWN. THERE IS AN SCRATCH MARK IN THE OUTER DIAMETER. THE SOURCE OF THE MARK IS MOST LIKELY FROM EXTRACTION. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: ITEM# 110017105 G7 FINNED 4 HOLE SHELL 56F LOT# 6229291; ITEM# 650-1058 CER BIOLOXD OPTION HD 40MM LOT# 2904568; ITEM# 51-107150 TPRLC 133 MP TYPE1 PPS HO 15.0 LOT# 6052045. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN INITIAL HIP PROCEDURE THE SURGEON ATTEMPTED TO SEAT LINER INTO CUP AND THE LINER DISENGAGED 3 TIMES. A NEW LINER WAS USED. ATTEMPTS WERE MADE FOR ADDITIONAL INFORMATION; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410601 G7 NEUTRAL E1 LINER 40MM F PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 6268009

    Patients

    Seq Age Sex Outcome Treatment
    1