BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAR POROUS LATERALIZED REDUCED DISTAL TAPERLOC FEMORAL STEM

    MDR report key: 6916763 · Received October 5, 2017

    Report

    Report Number
    0001825034-2017-07854
    Event Type
    Injury
    Date Received
    October 5, 2017
    Date of Event
    December 7, 2011
    Report Date
    November 2, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK030055
    Removal / Correction Number
    A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: 157958 HA M2A-MAGNUM PF CUP 58ODX52ID LOT# 1696121. 139272 M2A-MAGNUM 52-60MM TPR INSR +6 LOT# 1425611. 157452 M2A-MAGNUM MOD HD SZ 52MM LOT# 1509954. 13-103209 TAPERLOC POR RED/LAT 17.5X155 LOT# 758640. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO NOT BE REPORTABLE. THERE ARE NO ALLEGATIONS OF FAILURE OF THE DEVICE AND THE INITIAL REPORT WAS SUBMITTED IN ERROR.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED TO ADDRESS IMPLANT FRACTURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697541 MODULAR POROUS LATERALIZED REDUCED DISTAL TAPERLOC FEMORAL STEM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 758640

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R