BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RNGLC+ LTD HOLE FIN SHL SZ50

    MDR report key: 4092810 · Received September 16, 2014

    Report

    Report Number
    0001825034-2014-07724
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 19, 2014
    Report Date
    October 2, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK093235
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 WAS RELEASED WITH NO RECORDED ANOMALY RELATED TO THE EVENT. EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 0001825034 -2014 -07724 & 07727).

    Additional Manufacturer Narrative · 1

    THE RETURNED CUP INSERTER WAS RECEIVED IN A CONDITION THAT INDICATED THAT THE PART HAD BEEN USED EXTENSIVELY AS EVIDENCED BY A VISUAL EXAMINATION. THE VISUAL EXAMINATION REVEALED DAMAGED /CHIPPED TEETH ON THE REAR GEAR AND THE INSERTER SCREW. A DIMENSIONAL ANALYSIS WAS NOT PERFORMED DUE TO THE INSERTER BEING LOCKED-UP ON THE SHELL. BASED ON THIS INVESTIGATION, SINCE THE INSERTER SCREW THREAD WAS CONFORMING, IT APPEARS THAT ONCE THE INSERTER ENGAGED THE CUP AND A LOAD WAS APPLIED, THAT THE DAMAGED/CHIPPED TEETH MAY HAVE CONTRIBUTED TO THE IMPROPER FUNCTION OF THE INSERTER. THERE ARE WARNINGS IN THE IFU THAT STATE UNDER "CARE AND HANDLING OF INSTRUMENTS AND INSTRUMENT CASES¿: " GENERAL. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT ON (B)(6) 2014, THE INSERTER FRACTURED UPON IMPACTION OF THE ACETABULAR CUP AND A PIECE REMAINED IN THE CUP. THE CUP WAS REMOVED AND ANOTHER CUP WAS IMPACTED WITH A DIFFERENT INSERTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570970 RNGLC+ LTD HOLE FIN SHL SZ50 PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 320500

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R