BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVENIR CMPL HA HO NC SIZE 4

    MDR report key: 17875446 · Received October 5, 2023

    Report

    Report Number
    0001822565-2023-02697
    Event Type
    Injury
    Date Received
    October 5, 2023
    Date of Event
    June 5, 2023
    Report Date
    November 13, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    UDI-DI
    00889024508774
    PMA / PMN Number
    K182048
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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 G3 G6 H2 H6 PROPOSED COMPONENT CODE: MECHANICAL (G04)- STEM H10 NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: PERIPROSTHETIC FRACTURE OF THE PROXIMAL LEFT FEMUR. MILD SUBSIDENCE OF THE FEMORAL IMPLANT ON THE 2ND POST-OPERATIVE FILM. ALIGNMENT IS ANATOMIC. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 010000703, ITEM NAME G7 BONEMASTER LTD ACET SHL 52E, LOT # 74999907; 010000857, ITEM NAME G7 NEUTRAL E1 LINER 36MM E, LOT # 7412183; 00-8775-036-03, ITEM NAME BIOLOX DELTA HD 12/14 36X+3.5, LOT # 3154916. G2: FOREIGN: BELGIUM. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT¿S LOCATION IS NOT KNOWN; 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

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE 1 DAY POST IMPLANTATION DUE TO INTRA-OPERATIVE FRACTURE OF THE FEMUR THAT RESULTED IN STEM SUBSIDENCE. THE FRACTURE WAS VISIBLE ON THE POST OPERATIVE RADIOGRAPH. THE STEM WAS IMPLANTED AT THE CORRECT LEVEL WITHOUT SUBSIDENCE AND THE PATIENT WAS ABLE TO BARE WEIGHT. HOWEVER, THE SECOND RADIOGRAPH APPEARED TO SHOW SUBSIDENCE OF THE STEM RESULTING IN THE REVISION. ALL OTHER DEVICES REMAINED IMPLANTED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353487 AVENIR CMPL HA HO NC SIZE 4 PROSTHETIC, HIP LZO ZIMMER BIOMET, INC. N/A 3146583 00889024508774

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Unknown Hospitalization| R PLEASE SEE H10.