BEUDAMED
    FDA Adverse Event Injury Summary report: N

    52MM OD MAGNUM ACET INSTR

    MDR report key: 4440421 · Received January 22, 2015

    Report

    Report Number
    0001825034-2015-00226
    Event Type
    Injury
    Date Received
    January 22, 2015
    Date of Event
    January 7, 2015
    Report Date
    June 8, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO NOT BE REPORTABLE. A TRIAL FEMORAL STEM IS MEANT TO BE REMOVED FROM THE BODY; THEREFORE, THERE WAS NO PATIENT INJURY AS A RESULT OF THIS EVENT.

    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 AND TO REPORT DEVICE EVALUATION RESULTS. PRODUCT WAS RETURNED FOR EVALUATION ON (B)(4) 2015. EVALUATION OF THE RETURNED DEVICE CONFIRMED THAT IT DISENGAGED FROM THE INSERTER AS INTENDED.

    Additional Manufacturer Narrative · 1

    MDR NUMBER 1825034-2015-00226-2 WAS SENT IN ERROR DUE TO AN INCORRECT MFR NUMBER BEING USED. REPORTS NUMBERED 1825034-2015-00226-2 AND 1825034-2015-00226-3 MAY BE REMOVED FROM THE RECORD.

    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. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2015-00226 / 00227).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON JANUARY 7, 2015. DURING THE PROCEDURE, THE FOUR PRONGS OF THE INSERTER WOULD NOT DISENGAGE WHILE IMPACTING THE ACETABULAR CUP. THE ACETABULAR CUP WAS REMOVED AND ATTEMPTED TO BE REIMPLANTED WITH A CURVED INSERTER HANDLE WITHOUT SUCCESS. A LARGER ACETABULAR CUP WAS IMPLANTED AND A 40 MINUTE DELAY OCCURRED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52575 52MM OD MAGNUM ACET INSTR ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH BIOMET ORTHOPEDICS N/A 068520

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R