BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT CEMENTLESS SIZE 13.5

    MDR report key: 15335618 · Received September 1, 2022

    Report

    Report Number
    0001822565-2022-02524
    Event Type
    Injury
    Date Received
    September 1, 2022
    Date of Event
    August 11, 2022
    Report Date
    August 31, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024131910
    PMA / PMN Number
    K192660
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: REF 30123606 LOT 64594615 LINER- G7 VIVACET-E HIGHLY CROSSLINKED, SIZE 36 ID, HIGH WALL; REF 00877503604 LOT 2964399 BIOLOX CERAMIC HEAD SIZE 37, +7 (WINTERTHUR); REF 110010246 LOT 65300634 BIOMET G7 ACETABULAR SHELL WITH CLUSTER HOLES SIZE 56; REF 00625006540 LOT J6710215 BONE SCREW 6.5MM X 40 SELF-TAPPING ; REF 00625006535 LOT J7245457 BONE SCREW 6.5X35 SELF TAPPING. (B)(4). 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: THE PATIENT FELL GOING DOWN THE STAIRS AND UNDERWENT A REVISION THE SAME DAY. CABLES WERE PLACED TO REDUCE THE FRACTURE. THE STEM, HEAD AND LINER WERE REPLACED WITH ZIMMER PRODUCTS. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. IT WAS REPORTED THE PATIENT FELL DOWN THE STAIRS AND SUSTAINED A PERIPROSTHETIC FRACTURE. HOWEVER, AS THE REASON FOR THE FALL IS UNKNOWN, A DEFINITIVE ROOT CAUSE CANNOT 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

    IT WAS REPORTED THAT A PATIENT HAD A RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT FELL GOING DOWN STAIRS AND SUSTAINED A PERIPROSTHETIC FRACTURE. THE PATIENT UNDERWENT AN OPEN REDUCTION OF THE FRACTURE, WITH CERCLAGE CABLES, ALONG WITH A REVISION OF THE RIGHT HIP APPROXIMATELY 1.5 MONTHS LATER. THE ACETABULAR COMPONENT REMAINED WELL FIXED AND ALL OTHER COMPONENTS WERE REVISED. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2595261 FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT CEMENTLESS SIZE 13.5 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 63989036 00889024131910

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H