BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 TYPE1 BM SO 11.0

    MDR report key: 7757555 · Received August 7, 2018

    Report

    Report Number
    0001825034-2018-04729
    Event Type
    Injury
    Date Received
    August 7, 2018
    Date of Event
    June 8, 2018
    Report Date
    October 10, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PN/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM #010000850, LINER, LOT #6207406, ITEM #110010245, CUP, LOT #6240463, ITEM #6501162, HEAD, LOT #2018010531. EVENT OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF RADIOGRAPHS. OVERALL FIT AND ALIGNMENT ARE ANATOMIC. BONE QUALITY APPEARS NORMAL. MINIMAL SUBSIDENCE OF THE FEMORAL COMPONENT NOTED. REVIEW OF DEVICE HISTORY RECORDS FOUND THESE UNITS WERE RELEASED TO DISTRIBUTION WITH NO DEVIATIONS OR ANOMALIES. ROOT CAUSE WAS UNABLE TO BE DETERMINED WITH THE INFORMATION 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 VIA X-RAY REVIEW THAT PATIENT HAD EXPERIENCED SUBSIDENCE OF THE FEMORAL STEM APPROXIMATELY 6 WEEKS POST-IMPLANTATION. NO MEDICAL INTERVENTION HAS YET BEEN TAKEN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599425 TPRLC 133 TYPE1 BM SO 11.0 HIP PROSTHESIS KWA ZIMMER BIOMET, INC. N/A 6180897

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other