BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STEM

    MDR report key: 7564885 · Received June 4, 2018

    Report

    Report Number
    0001825034-2018-03683
    Event Type
    Injury
    Date Received
    June 4, 2018
    Report Date
    April 12, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF 2D CONSTRUCTION IMAGES. THE REVIEW IDENTIFIED THE FEMUR BONE WAS FRACTURED. NO OTHER EVALUATION CAN BE PERFORMED FROM THESE IMAGES. FOLLOW UP INFORMATION SUGGESTS THAT THE PATIENT HAD A FALL AND THAT CAUSED THE FRACTURE; HOWEVER, THIS CANNOT BE CONFIRMED WITHOUT MEDICAL RECORDS.  DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM# S661140 SELEX/MAGNUM MOD HD 40MM +6 LOT# 825610. ITEM# EP-107927 E-POLY 40MM HIWALL LRN SZ27 LOT# 974510. ITEM# 11-106066 R/B RLOC LHOLE SHL 66MM SZ 27 LOT# 002680. ITEM# PT-210358 REGENEREX AUGMENT 58MM LG LOT# 394480. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS 0001825034-2018-03689.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL RIGHT HIP ARTHROPLASTY APPROXIMATELY 10 YEARS AGO. PATIENT EXPERIENCED A FALL ON UNKNOWN DATE RESULTING IN A TRANSVERSE FEMUR FRACTURE BELOW THE CEMENTED STEM AND HAS A LOOSE ACETABULAR COMPONENT. SALES REP INFORMED PATIENT DIAGNOSED WITH OSTEOLYSIS. PATIENT WILL UNDERGO REVISION IN NEAR FUTURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407816 UNKNOWN STEM PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other