BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC COMPETE PRIMARY FEMORAL POROUS COSTED STEM 16X 152MM HIGH OFFSET TYPE 1

    MDR report key: 6708464 · Received July 12, 2017

    Report

    Report Number
    0001825034-2017-04576
    Event Type
    Injury
    Date Received
    July 12, 2017
    Date of Event
    March 21, 2017
    Report Date
    February 8, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK101086
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO REPORT ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS- PART: 110017104 NAME: G7 FINNED 4 HOLE SHELL 54F LOT: 3703149, PART: 010000858 NAME: G7 NEUTRAL E1 LINER 36 MM F LOT: 3794200, PART: 650-1065 NAME: CER OPTION TYPE 1 TPR SLEVE -3 LOT: 843120, PART: 650-1057 NAME: CER BIOLOXD OPTION HD 36 MM LOT: 100590.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCT(S): UNKNOWN CUP. UNKNOWN LINER. UNKNOWN HEAD. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CORRECTED: STERILE EXPIRY DATE. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS 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.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT IS EXPERIENCING LIMPING AND IS UNABLE TO PUT WEIGHT ON THEIR RIGHT HIP APPROXIMATELY 5 MONTHS POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487739 TAPERLOC COMPETE PRIMARY FEMORAL POROUS COSTED STEM 16X 152MM HIGH OFFSET TYPE 1 PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 3595059

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other