BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 MP TYPE1 BM HO 16.0

    MDR report key: 7965942 · Received October 15, 2018

    Report

    Report Number
    0001825034-2018-09685
    Event Type
    Injury
    Date Received
    October 15, 2018
    Date of Event
    September 21, 2018
    Report Date
    October 12, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PNOT CLEARED
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM# 010000705, G7 BONEMASTER LTD ACET SHL 56F, LOT# 3939717; ITEM# 010000858, G7 NEUTRAL E1 LINER 36MM F, LOT# 6248601; ITEM# 650-0841, 36MM COCR BIOMET FEM HD STD NK, LOT# 3932014. FOREIGN SOURCE: (B)(6). REPORTED EVENT WAS CONFIRMED BY REVIEW OF XRAYS WHICH INDICATED NORMAL ANATOMIC ALIGNMENT. HOWEVER, AREAS OF PERIPROSTHETIC LUCENCY ARE NOTED ALONG THE MEDIAL PORTION OF THE DISTAL FEMORAL STEM AND POSSIBLY ALONG THE LATERAL ASPECT OF THE SUBTROCHANTERIC PORTION OF THE FEMORAL STEM. LUCENCY SUGGESTS LOOSENING, BONE QUALITY APPEARS NORMAL. 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 · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION 2 MONTHS POST IMPLANTATION DUE TO STEM LOOSENING. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808305 TPRLC 133 MP TYPE1 BM HO 16.0 PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 3975954

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R