BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H10

    MDR report key: 7564889 · Received June 4, 2018

    Report

    Report Number
    0001825034-2018-03689
    Event Type
    Injury
    Date Received
    June 4, 2018
    Report Date
    April 12, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDG
    PMA / PMN Number
    PSEE H10
    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 UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. 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 · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). 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. REVIEW OF INVOICE HISTORY WAS UNABLE TO DETERMINE THE EXACT IDENTIFICATION OF THE DEVICE INVOLVED IN THE REPORTED EVENT. THIS REPORT IS BEING SUBMITTED FOR: BRAND NAME-REGENEREX ACET SHELL 76ODX66ID, (B)(4), CATALOG NUMBER: PT-126676, LOT NUMBER-374500, EXPIRATION DATE- SEPTEMBER 9, 2016, PMA/510K-K052996, MANUFACTURER DATE: SEPTEMBER 21 2006, OR BRAND NAME-RAN/BUR RNGLC SHL 66MM SZ 27, (B)(4), CATALOG NUMBER: 106066, LOT NUMBER-002680, EXPIRATION DATE- MARCH 31, 2014, PMA/510K-K911685, MANUFACTURER DATE: MARCH, 31, 2004. 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# PT-210358 REGENEREX AUGMENT 58MM LG LOT# 394480, ITEM # UNKNOWN ,UNKNOWN STEM LOT# UNKNOWN . 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
    407818 SEE H10 PROSTHESIS, HIP JDG ZIMMER BIOMET, INC. N/A SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other