BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RNGLC+ LTD HOLE FIN SHELL SZ50

    MDR report key: 3800800 · Received May 8, 2014

    Report

    Report Number
    0001825034-2014-03694
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 3, 2014
    Report Date
    August 22, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND EVIDENCE OF PRODUCT NON-CONFORMANCE. EVALUATION OF RETURNED DEVICE FOUND IMPLANT TO BE OUT OF DESIGN SPECIFICATIONS. FURTHER INVESTIGATION HAS BEEN INITIATED TO ADDRESS THE REPORTED ISSUE.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO CORRECT INFORMATION.

    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. EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT HIP HEMI-ARTHROPLASTY PROCEDURE ON (B)(6) 2014 AND WAS REVISED ON (B)(6) 2014 DUE TO DISLOCATION FROM A FALL. DURING THE REVISION PROCEDURE, THE ACETABULAR LINER WOULD NOT ENGAGE WITH THE ACETABULAR CUP. ANOTHER ACETABULAR CUP AND LINER WERE AVAILABLE TO COMPLETE THE PROCEDURE; HOWEVER, A DELAY GREATER THAN THIRTY MINUTES AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279337 RNGLC+ LTD HOLE FIN SHELL SZ50 PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 537940

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R