BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAR POROUS LATERALIZED REDUCED DISTAL TAPERLOC FEMORAL

    MDR report key: 5986344 · Received September 29, 2016

    Report

    Report Number
    0001825034-2016-03854
    Event Type
    Injury
    Date Received
    September 29, 2016
    Date of Event
    October 20, 2015
    Report Date
    June 9, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THIS REPORT IS NUMBER 3 OF 3 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-03805, 03851, 03854).

    Additional Manufacturer Narrative · 1

    (B)(6). CONCOMITANT PRODUCTS - M2A-MAGNUM MOD HD SZ 52MM/ PN 157452/ LN 134710, M2A-MAGNUM 52-60MM TPR INS STD/ PN 139268/ LN 953510. NO DEVICES OR PHOTOS OF THE DEVICES WERE RECEIVED; THEREFORE, THE CONDITION OF THE COMPONENTS IS UNKNOWN. ADDITIONALLY, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE PRODUCT NUMBER AND THE LOT NUMBER WERE NOT PROVIDED; THEREFORE, THE MANUFACTURING DATE, THE DEVICE HISTORY RECORDS AND THE FIELD AGE OF THE DEVICE COULD NOT BE DETERMINED. THERE IS INSUFFICIENT INFORMATION TO PERFORM A COMPLAINT HISTORY SEARCH. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    OPERATIVE REPORT RECEIVED FROM PATIENT'S LEGAL COUNSEL REPORTED THAT DURING A RIGHT HIP REVISION PROCEDURE, THE FEMORAL HEAD COLD WELDED TO THE TRUNNION. THIS RESULTED IN THE STEM BEING REMOVED AND A 20 MINUTE DELAY IN PROCEDURE. DURING REMOVAL OF THE STEM, THE PATIENT'S FEMUR FRACTURED ANTERIORLY. THE FRACTURE WAS STABILIZED WITH A PLATE AND CABLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638859 MODULAR POROUS LATERALIZED REDUCED DISTAL TAPERLOC FEMORAL PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 363050

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R