BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STR INSERTER 1/4-28 THRD KIT

    MDR report key: 4251162 · Received November 14, 2014

    Report

    Report Number
    0001825034-2014-08630
    Event Type
    Injury
    Date Received
    November 14, 2014
    Report Date
    February 17, 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
    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

    EXAMINATION OF RETURNED DEVICE FOUND EVIDENCE OF PRODUCT NON-CONFORMANCE. DURING THE EVALUATION IT WAS NOTED THE ROOT CAUSE OF THE EVENT WAS MOST LIKELY DUE TO AN IMPROPER HEAT TREATMENT PROCESS. CORRECTIVE ACTION HAS BEEN INITIATED TO ADDRESS THE REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE TIP OF THE STRAIGHT CUP INSERTER FRACTURED IN THE PATIENT. THE CUP WAS IMPLANTED AND THE FRACTURED TIP REMAINS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736077 STR INSERTER 1/4-28 THRD KIT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH BIOMET ORTHOPEDICS N/A ZB111101

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention