BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FITMORE®, HIP STEM, UNCEMENTED, B/7, TAPER 12/14

    MDR report key: 18379219 · Received December 21, 2023

    Report

    Report Number
    0009613350-2023-00707
    Event Type
    Injury
    Date Received
    December 21, 2023
    Date of Event
    July 15, 2020
    Report Date
    March 1, 2024
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWY
    UDI-DI
    00889024393745
    PMA / PMN Number
    K192236
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORIES FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. WITH THE AVAILABLE INFORMATION, 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 REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(6) G2: FOREIGN: GERMANY D10: 32MM I.D. SIZE HH NEUTRAL LINER USE WITH 50MM O.D. SIZE HH SHELL ITEM # 00875100932 LOT #61616435 BIOLOX® FORTE, HEAD, S, ø 32/-4, TAPER 12/14 ITEM # 123205 LOT #2616162 ALLOFIT® IT ALLOCLASSIC®, SHELL FOR ACETABULUM, UNCEMENTED, 50/HH ITEM #00875505000 LOT # 2611175 THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CLINICAL THAT A PATIENT UNDERWENT AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2011. SUBSEQUENTLY, ON (B)(6) 2020, THE PATIENT UNDERWENT A REVISION OF THE FEMORAL HEAD AND STEM DUE TO A TRAUMATIC FRACTURE OF THE FEMORAL SHAFT. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306126 FITMORE®, HIP STEM, UNCEMENTED, B/7, TAPER 12/14 HIP IMPLANT KWY ZIMMER GMBH N/A 2612021 00889024393745

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Hospitalization| R SEE NARRATIVE H10.