BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL STEM 12/14 NECK TAPER PRESS-FIT CEMENTLESS SIZE 10 STANDARD OFFSET

    MDR report key: 19459330 · Received June 4, 2024

    Report

    Report Number
    0001822565-2024-01859
    Event Type
    Injury
    Date Received
    June 4, 2024
    Date of Event
    April 17, 2024
    Report Date
    July 31, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00889024131781
    PMA / PMN Number
    K200823
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    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: B4, G3, G6, H2, H3, H6, H11. H6 - COMPONENT CODE - PROPOSED CODE IS MECHANICAL (G04) - STEM. RADIOGRAPHIC REVIEW CONFIRMED LOOSE HIP STEM WITH LACK OF OSTEOINTEGRATION AND OPERATIVE NOTES CONFIRMED A REVISION WAS PERFORMED TO ADDRESS FEMORAL COMPONENT LOOSENING AND FEMORAL COMPONENT PROXIMAL FEMUR FRACTURE. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: MEDICAL PRODUCT: BIOLOX® DELTA, CERAMIC FEMORAL HEAD, S, ø 28/-3.5, TAPER 12/14: CATALOG#00877502801, LOT#3032327; VIVACIT-E DM BEARING 28X44MM: CATALOG#110031012, LOT#65207667; G7 DUAL MOBILITY LINER 44MM F: CATALOG#110024464, LOT#456780; G7 PPS LTD ACET SHELL 56F: CATALOG#010000665, LOT#7080192 CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT HAS BEEN DISCARDED. THE INVESTIGATION IS IN PROCESS. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT REPORTED CONTINUED PAIN WITH ACTIVITY AND WAS AMBULATING WITH A CANE. DIAGNOSTICS REVEALED A LOOSE FEMORAL STEM WITH LACK OF OSTEOINTEGRATION AS WELL AS RADIOLUCENCY AND SUBSIDENCE. APPROXIMATELY TWO (2) YEARS AND FIVE (5) MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT REVISION SURGERY WHICH FURTHER REVEALED GROSS MOTION OF THE FEMORAL STEM AND A PROXIMAL FEMUR FRACTURE. THE FEMORAL STEM, HEAD, AND BEARING WERE REVISED WITHOUT COMPLICATION. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150080 FEMORAL STEM 12/14 NECK TAPER PRESS-FIT CEMENTLESS SIZE 10 STANDARD OFFSET PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. 65006716 00889024131781

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Hospitalization| R