BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAR FEMORAL STEM PRESS-FIT

    MDR report key: 14086169 · Received April 12, 2022

    Report

    Report Number
    0001822565-2022-01030
    Event Type
    Injury
    Date Received
    April 12, 2022
    Date of Event
    March 2, 2022
    Report Date
    April 11, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024132641
    PMA / PMN Number
    K182678
    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 00-8775-032-02 LOT 3072132 BIOLOX HEAD. REF 00-7848-013-00 LOT 64678797 KINECTIV NECK. REF 00-6305-50-32 LOT 64893930 ACETABULAR LINER. REF 00-6250-65-30 LOT J7146602 BONE SCREW. REF 00-6250-65-20 LOT 64714735 BONE SCREW. REF 00-6202-54-22 LOT 64843944 SHELL. REPORTED EVENT WAS CONFIRMED DUE TO THE REVIEW OF MEDICAL RECORDS. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: AN INITIAL LEFT THA WAS PERFORMED. A REVISION OCCURRED DUE TO THE PATIENT FALLING BACKWARDS. AN ECHO CONFIRMED THE FRACTURE. THE POSTERIOR CAPSULE WAS TORN OFF THE TROCHANTER, WHICH WAS SECURED WITH CABLES. NO COMPLICATIONS NOTED, THE HEAD, NECK AND STEM WERE REVISED WITH ZIMMER PRODUCTS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. IT WAS REPORTED THAT THE PATIENT FELL. HOWEVER, AS THE REASON FOR THE FALL IS UNKNOWN, 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2022 - 01029.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 1 MONTH POST IMPLANTATION DUE TO A PERIPROSTHETIC FRACTURE FROM A FALL. THE HEAD, NECK, AND STEM WERE EXCHANGED WITH ADDITION OF CERCLAGE CABLES TO STABILIZE THE FRACTURE WITHOUT COMPLICATIONS. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209608 MODULAR FEMORAL STEM PRESS-FIT PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 65229970 00889024132641

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R