BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT

    MDR report key: 11373031 · Received February 24, 2021

    Report

    Report Number
    0001822565-2021-00508
    Event Type
    Injury
    Date Received
    February 24, 2021
    Date of Event
    September 8, 2019
    Report Date
    June 30, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    K192660
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: G3; H2; H3; H6. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: REVISION OP NOTES WERE REVIEWED AND IDENTIFIED LEFT PERIPROSTHETIC HIP FRACTURE WITH LOOSE FEMORAL COMPONENT. PATIENT HAD A FALL AND SUBSEQUENTLY WAS FOUND TO HAVE FRACTURE OF THE FEMORAL SHAFT EXTENDING UP TO THE LOCATION OF THE IMPLANT WITH INSTABILITY OF THE FEMORAL COMPONENT. THE FLUID IN THE HIP APPEAR TO BE HEMATOMA AND THERE WAS NO OBVIOUS ABNORMAL FLUID OTHERWISE. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. IT WAS REPORTED PATIENT FELL AND SUSTAINED A FRACTURE. HOWEVER, WITHOUT ADDITIONAL DETAILS 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: ITEM#00877703202 / ITEM NAME BIOLOX® OPTION, HEAD, M, ø 32/0, TAPER 12/14 / LOT#2842953. ITEM#11-300817 / ITEM NAME ARCOS 17X150MM SPL TPR DIST / LOT#438320. ITEM#11-301302 / ITEM NAME ARCOS CON SZ B STD 60MM / LOT#215470. ITEM#12-115115 / ITEM NAME CER BIOLOXD MOD HD 32MM STD NK / LOT#2971484. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS LOCATION IS UNKNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT A LEFT THA AND WAS REVISED ON 7 YEARS LATER DUE TO ELEVATED METAL ION LEVELS, ALTR, NECROSIS, PAIN, SCAR TISSUE, AND IN-VIVO CORROSION. SUBSEQUENTLY, THE PATIENT FELL AND SUSTAINED A PERIPROSTHETIC FRACTURE WITH FEMORAL LOOSENING AND INSTABILITY AND WAS REVISED 9 MONTHS AFTER THE FIRST REVISION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271398 FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT PROSTHETIC, HIP LZO ZIMMER BIOMET, INC. N/A 62155228

    Patients

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