BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABG II CUP&CERAMIC INS PK W/HL

    MDR report key: 3163099 · Received June 11, 2013

    Report

    Report Number
    0002249697-2013-01889
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE PROVIDED INFORMATION, THE PRODUCT REPORTED DID NOT CONTRIBUTE TO THE EVENT.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THE SUBJECT DEVICE IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S.

    Description of Event or Problem · 1

    THE PHARMACIST AT THE CLINIC REPORTED THAT "WHEN OPENING THE DEVICE, THE OUTER PACKAGING WAS FINE, BUT THE INNER PACKAGING WAS STAINED. ANOTHER DEVICE WAS USED FOR THE SURGERY." UPDATE: FURTHER COMMUNICATION WITH THE CUSTOMER CONCLUDED, THAT THE PROBLEM WITH THE PACKAGING WAS AN INTERNAL PROBLEM.

    Description of Event or Problem · 1

    THE PHARMACIST AT THE CLINIC REPORTED THAT "WHEN OPENING THE DEVICE, THE OUTER PACKAGING WAS FINE, BUT THE INNER PACKAGING WAS STAINED. ANOTHER DEVICE WAS USED FOR THE SURGERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264338 ABG II CUP&CERAMIC INS PK W/HL IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH G2904680C

    Patients

    Seq Age Sex Outcome Treatment
    1 Other