BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 STR MONOBLOCK SHELL INSRTR

    MDR report key: 5033197 · Received August 26, 2015

    Report

    Report Number
    0001825034-2015-03838
    Event Type
    Injury
    Date Received
    August 26, 2015
    Date of Event
    July 27, 2015
    Report Date
    October 26, 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
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION AND ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. PRODUCT LEFT CONFORMING TO PRINT AS THERE WAS NO EVIDENCE THAT STATES OTHERWISE. THE ACETABULAR INSERTER¿S THREADS HAD FRACTURED AS STATED IN THE COMPLAINT. PRODUCT LIKELY FAILED DUE TO MISUSE, AS HANDLES WERE DESIGNED TO SEAT AGAINST THE BOTTOM OF THE THREADS IN THE CUP. IF THE HANDLE IS NOT TIGHTENED DOWN COMPLETELY AGAINST THIS FEATURE, DAMAGE TO THE THREADS OF THE HANDLE IS POSSIBLE. THE RETURNED CUP SHOWS THE FRACTURED OFF THREADS THAT REMAIN IN THE CUP ARE NOT ALL THE WAY THREADED INTO THE CUP. THE FRACTURE PATTERN ON THE INSERTER¿S THREADS ALSO INDICATE THAT THE SURGEON LEVERED THE ATTACHED INSERTER HANDLE WHILE ATTEMPTING TO REPOSITION THE TRIAL OR DEFINITIVE COMPONENT WHICH THE INSERTER WAS NOT DESIGNED TO DO. BASED ON THESE RESULTS THE COMPLAINT IS CONSIDERED CONFIRMED.

    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: UNDER PRECAUTIONS STATES, ¿INTRAOPERATIVE FRACTURE OR BREAKING OF INSTRUMENTS HAS BEEN REPORTED FOR GENERAL INSTRUMENTS.¿ 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL HIP ARTHROPLASTY ON (B)(6) 2015, THE G7 INSERTER FRACTURED OFF INSIDE THE CUP. IT WAS WEDGED IN WHERE IT COULD NOT BE REMOVED FROM THE CUP. ANOTHER CUP WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565370 G7 STR MONOBLOCK SHELL INSRTR PROSTHESIS, HIP LKD BIOMET ORTHOPEDICS N/A 415080

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention