BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL STEM 12/14

    MDR report key: 12737886 · Received November 2, 2021

    Report

    Report Number
    0002648920-2021-00385
    Event Type
    Injury
    Date Received
    November 2, 2021
    Date of Event
    October 11, 2021
    Report Date
    December 9, 2021
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JDI
    UDI-DI
    00889024145788
    PMA / PMN Number
    K191735
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: B4, B5, G3, H2, H3, H4, H6. REPORTED EVENT WAS CONFIRMED DUE TO THE REVIEW OF MEDICAL RECORDS. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: PERIPROSTHETIC FRACTURE OF THE RIGHT TOTAL HIP ARTHROPLASTY ADJACENT TO THE FEMORAL STEM. NONSPECIFIC INCIDENTAL NOTE MADE OF DECREASED LATERAL INCLINATION OF THE ACETABULAR CUP. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. 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: CAT#8018-28-14 LOT#62747878 FEMORAL HEAD 28MM PLUS 7MM. CAT#EP-200144 LOT#719370DUAL MOBILITY BEARING G7. FOREIGN: COUNTRY: (B)(6). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 3 YEARS POST IMPLANTATION DUE TO A PERI PROSTHETIC FRACTURE OF RIGHT FEMUR. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1637335 FEMORAL STEM 12/14 PROSTHESIS, HIP JDI ZIMMER MANUFACTURING B.V. N/A 64005725 00889024145788

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Female Hospitalization| R SEE H10 NARRATIVE