BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC POR LAT FMRL 12.5X145

    MDR report key: 3955020 · Received July 24, 2014

    Report

    Report Number
    0001825034-2014-06423
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    July 8, 2014
    Report Date
    February 25, 2022
    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
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THESE TYPES OF EVENTS CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 14 STATES, "POSTOPERATIVE BONE FRACTURE AND PAIN."

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. IF ANY FURTHER INFORMATION IS FOUND THAT WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2013. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2014 DUE TO PAIN AND STEM SINKING INTO THE FEMUR. AN INVOICE HISTORY COULD NOT BE LOCATED TO CONFIRM THE SURGERY DATES AND WHICH COMPONENTS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434439 TAPERLOC POR LAT FMRL 12.5X145 PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 997880

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Hospitalization| R