BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 FP TYPE1 BM HO 10.0

    MDR report key: 8063573 · Received November 13, 2018

    Report

    Report Number
    0001825034-2018-10525
    Event Type
    Injury
    Date Received
    November 13, 2018
    Date of Event
    February 20, 2017
    Report Date
    January 24, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 010000703 ¿ G7 ACETABULAR SHELL ¿ 3737299; 010000935 ¿ G7 LINER ¿ 3240895; 650-0661 ¿ DELTA CERAMIC HEAD ¿ 2016022125. (B)(6). THIS PRODUCT IS NOT CLEARED FOR DISTRIBUTION IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS A SIMILAR DEVICE IS CLEARED FOR DISTRIBUTION UNDER 510K NUMBER K101086. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT SUFFERED PAIN AROUND TROCHANTERIC BURSA ON LEFT SIDE WHEN WEIGHT BEARING APPROXIMATELY 6 MONTHS POST LEFT PARTIAL HIP ARTHROPLASTY. APPROXIMATELY 10 MONTHS POST ONSET OF PAIN, PATIENT RECEIVED A STEROID INJECTION UNDER ULTRASOUND GUIDANCE AT THE LEFT GREATER TROCHANTER. 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
    904455 TPRLC 133 FP TYPE1 BM HO 10.0 PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 3684127

    Patients

    Seq Age Sex Outcome Treatment
    1 Other