BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC POROUS FEMORAL STEM

    MDR report key: 6834604 · Received August 31, 2017

    Report

    Report Number
    0001825034-2017-06892
    Event Type
    Injury
    Date Received
    August 31, 2017
    Date of Event
    July 16, 2009
    Report Date
    August 31, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034 -2017 -06892, 0001825034 -2015 -04655, 0001825034 -2015 -04655-1, 0001825034 -2015 -04655- 2, 0001825034 -2015 -04655 -3, 0001825034-2015-04656, 0001825034-2015-04656-1, 0001825034-2015-04656-2, 0001825034-2015-04656-3, 0001825034-2015-04349, 0001825034-2015-04349-1, 0001825034-2015-04349-2, 0001825034-2015-04349-3, 0001825034-2015-04349-4, 0001825034-2017-06895, 0001825034-2017-06893, 0001825034-2017-06892. NO DEVICE WAS RETURNED FOR MANUFACTURER EVALUATION: P/N 157442 M2A-MAGNUM MOD HD SZ 42MM L/N 262230, P/N 157442 M2A-MAGNUM MOD HD L/N 571380, P/N US157848 M2A-MAGNUM PF CUP L/N 134680, P/N 103201 TAPERLOC POR FMRL L/N 303430, P/N 11-104110 M-H PC 10X155MM T1 L/N 008790, P/N 139254 M2A-MAGNUM 42-50MM INSERT L/N 637710. EXAMINATION OF THE REPORTED DEVICE(S) WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER RELATED REPORTS AGAINST THE PROVIDED PRODUCT/LOT CODE COMBINATIONS. A REVIEW OF DEVICE HISTORY RECORDS IDENTIFIED NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. MEDICAL RECORDS AND X-RAYS WERE REVIEWED. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION MADE AVAILABLE. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS HAS NOT BEEN INDICATED AS A RESULT OF THIS INVESTIGATION. ZIMMER BIOMET CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. 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 · 1

    IT WAS REPORTED THE PATIENT WAS REVISED APPROXIMATELY 2 YEARS POST-IMPLANT DUE TO PAIN. DURING THE PROCEDURE, THE FEMORAL HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED AND A FEMORAL OSTEOTOMY WAS PERFORMED TO REPLACE THE FEMORAL STEM. THE PATIENT UNDERWENT PHYSICAL THERAPY APPROXIMATELY 10 TIMES AFTER THE REVISION PROCEDURE. THE PATIENT WAS REVISED A SECOND TIME 6 YEARS LATER DUE TO METALLOSIS, ELEVATED METAL ION LEVELS, ADVERSE TISSUE REACTION, SQUEAKING OF THE JOINT, PAIN, AMBULATION DIFFICULTIES, AND METALLIC ODOR OF THE BREATH AND BOWELS. DURING THE PROCEDURE, METAL STAINED TISSUE AND METAL DEBRIS WERE ENCOUNTERED AND METALLIC BROWN FLUID WAS REMOVED FROM THE JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613864 TAPERLOC POROUS FEMORAL STEM PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 303430

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R