BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC 133 TYPE1 PPS HO 11.0

    MDR report key: 4651493 · Received April 2, 2015

    Report

    Report Number
    0001825034-2015-01250
    Event Type
    Injury
    Date Received
    April 2, 2015
    Date of Event
    January 26, 2011
    Report Date
    March 15, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK101086
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "POSTOPERATIVE BONE FRACTURE AND PAIN."

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ITEM # 163668, HEAD, LOT # 918770, ITEM # 135300, ACETABULAR PLUG, LOT # 723350, ITEM # EP-105933, LINER, LOT # 213790, ITEM # 11-104052, CUP, LOT # 957600. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. ROOT CAUSE WAS UNABLE TO 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 WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT ENROLLED IN A CLINICAL STUDY AND UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2011 DUE TO A PERIPROSTHETIC FRACTURE AFTER NEARLY FALLING. THE MODULAR HEAD AND FEMORAL STEM WERE REMOVED AND REPLACED AND CABLES WERE IMPLANTED TO ADDRESS THE FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220168 TAPERLOC 133 TYPE1 PPS HO 11.0 PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 2203670

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| R