BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M-H 3 HOLE SHELL PC DIA50MM LN 23

    MDR report key: 4005719 · Received August 13, 2014

    Report

    Report Number
    0001825034-2014-07029
    Event Type
    Injury
    Date Received
    August 13, 2014
    Date of Event
    July 15, 2014
    Report Date
    October 14, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. 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

    THE RETURNED PRODUCT WAS EVALUATED AND WAS FOUND TO HAVE BEEN MANUFACTURED WITHIN SPECIFICATIONS. A VISUAL EXAMINATION INDICATES A FRACTURE TOOK PLACE IN THE DRIVER ASSEMBLY, 31-100588-10, THAT CAUSED THE INSTRUMENT NOT TO FUNCTION AS INTENDED RESULTING IN THE INSTRUMENT LOCKING INSIDE THE SHELL. UNIT HAD BEEN IN SERVICE FOR OVER 8 YEARS.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2014. DURING THE PROCEDURE, THE INSERTER HANDLE WOULD NOT DISENGAGE FROM THE ACETABULAR CUP. ANOTHER ACETABULAR CUP WAS UTILIZED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484075 M-H 3 HOLE SHELL PC DIA50MM LN 23 PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 3310053

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R