BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 STR MONOBLOCK SHELL INSRTR

    MDR report key: 5093503 · Received September 22, 2015

    Report

    Report Number
    0001825034-2015-04051
    Event Type
    Injury
    Date Received
    September 22, 2015
    Date of Event
    September 8, 2015
    Report Date
    October 9, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LKD
    PMA / PMN Number
    PK121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    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 THIS TYPE OF EVENT CAN OCCUR: ¿INTRAOPERATIVE FRACTURE OR BREAKING OF INSTRUMENTS HAS BEEN REPORTED FOR GENERAL INSTRUMENTS.¿ 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

    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

    EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. EVALUATION OF RETURNED DEVICE FOUND THE ACETABULAR INSERTER¿S THREADS HAD FRACTURED AS STATED IN THE COMPLAINT. PRODUCT LIKELY FAILED DUE TO MISUSE BY PRODUCT BEING PUT THROUGH BENDING OVERLOAD FORCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2015. DURING THE PROCEDURE, THE G7 INSERTER THREADS FRACTURED DURING IMPACTION OF INSERTING THE CUP. THE CUP WAS WELL FIXED SO THE SURGEON DECIDED TO LEAVE IT; THE THREADS REMAINED IN THE CUP. THERE WAS NO DELAY IN PROCEDURE. THE SURGEON USED A FACE PLATE IMPACTOR TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626835 G7 STR MONOBLOCK SHELL INSRTR PROSTHESIS, HIP LKD BIOMET ORTHOPEDICS N/A 280640

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Disability