BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 MP TYPE1 PPS HO 15.0

    MDR report key: 4092548 · Received September 16, 2014

    Report

    Report Number
    0001825034-2014-07710
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    April 11, 2014
    Report Date
    September 19, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK110400
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED. EXPIRATION DATE - UNKNOWN; MANUFACTURE DATE - UNKNOWN. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CLINICAL STUDY PATIENT UNDERWENT AN INITIAL LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2014. SUBSEQUENTLY, THE PATIENT HAD A REVISION ON (B)(6) 2014 DUE TO PERIPROSTHETIC FRACTURE. REVIEW OF INVOICE HISTORY VERIFIED THE IMPLANT AND REVISION SURGERY DATES. THE MODULAR HEAD, TAPER ADAPTER AND STEM WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572551 TPRLC 133 MP TYPE1 PPS HO 15.0 PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 3211283

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R