BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 BONEMASTER LTD ACET SHL 52E

    MDR report key: 6754183 · Received July 31, 2017

    Report

    Report Number
    0001825034-2017-05053
    Event Type
    Injury
    Date Received
    July 31, 2017
    Date of Event
    May 11, 2017
    Report Date
    November 9, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTIONS ARE REQUIRED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT - G7 HI-WALL E1 LINER 36 MM E CATALOG # 010000935 LOT# 6020027, DELTA CERAMIC FEM HD 36/-3 MM CATALOG # 650-0660 LOT# 2016041027, TPRLC 133 FP TYPE1 BM SO 10.0 CATALOG # 51-110100 LOT# 3491450. THERAPY DATE: (B)(6) 2017. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. REPORTS: 0001825034 - 2017 - 05275, 0001825034 - 2017 - 04957, 0001825034 - 2017 - 05274. G7 BONEMASTER LTD ACET SHL 52E: THIS DEVICE IS NOT CLEARED FOR DISTRIBUTION IN THE US; HOWEVER A SIMILAR DEVICE IS UNDER 510K K050441 AND PRODUCT CODE IS JDI.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT LEFT HIP ARTHROPLASTY THE PATIENT DEVELOPED SWELLING AND TENDERNESS OF THE LEG DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533784 G7 BONEMASTER LTD ACET SHL 52E PROSTHESIS HIP JDI BIOMET ORTHOPEDICS N/A 3976916

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R