BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 STR INSERTER THREADED SHAFT

    MDR report key: 4820962 · Received June 5, 2015

    Report

    Report Number
    0001825034-2015-02432
    Event Type
    Injury
    Date Received
    June 5, 2015
    Date of Event
    May 8, 2015
    Report Date
    July 13, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    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: UNDER CARE AND HANDLING OF INSTRUMENTS, NUMBER 1 STATES, "SURGICAL INSTRUMENTS AND INSTRUMENT CASES ARE SUSCEPTIBLE TO DAMAGE FOR A VARIETY OF REASONS INCLUDING PROLONGED USE, MISUSE, ROUGH OR IMPROPER HANDLING. CARE MUST BE TAKEN TO AVOID COMPROMISING THEIR EXACTING PERFORMANCE." DEVICE AVAILABILITY - THE DEVICE IS REPORTED TO BE AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED BY BIOMET ORTHOPEDICS TO DATE. IN THE EVENT THAT THE DEVICE IS RECEIVED AND EVALUATED, A FOLLOW UP REPORT WILL BE SENT TO THE FDA TO PROVIDE RESULTS.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. PRODUCT LIKELY FAILED DUE TO MISUSE, BY PRODUCT BEING PUT THROUGH BENDING OVERLOAD, AND/OR NOT INSPECTED FOR WEAR AND DISFIGUREMENT PRIOR TO USE, WHICH MAY HAVE PREVENTED THE USE OF THE INSTRUMENT AND ITS FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2015. DURING THE PROCEDURE, THE THREAD OF THE IMPACTOR FRACTURED WHILE INSERTING THE ACETABULAR CUP. AS A RESULT, PART OF THREAD WAS STUCK IN THE APICAL HOLE OF THE CUP. THE ACETABULAR CUP WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364201 G7 STR INSERTER THREADED SHAFT PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 380316

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R