BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRAIGHT MBLOC ACETABULAR SHELL INSERTER

    MDR report key: 5821998 · Received July 26, 2016

    Report

    Report Number
    0001825034-2016-02735
    Event Type
    Malfunction
    Date Received
    July 26, 2016
    Report Date
    April 13, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    PBI
    PMA / PMN Number
    PK121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. PRODUCT REQUESTED, NOT YET RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS - EXCEED ACETABULAR CUP, CATALOG#: 131354, LOT#: 3714188. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE FRACTURE PATTERN OF THE THREADS IS CONSISTENT WITH BENDING OVERLOAD. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE OF THE REPORTED EVENT WAS UNABLE TO BE DETERMINED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTRIBUTE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE INSERTER WAS DAMAGED. NO OTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE INSERTER FRACTURED. THE TIP OF THE INSERTER REMAINED IN THE CUP; THEREFORE, THE CUP WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476389 STRAIGHT MBLOC ACETABULAR SHELL INSERTER PROSTHESIS, HIP PBI BIOMET ORTHOPEDICS N/A 636740

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention