BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPACT ACETABULAR SHELL Ø46 TWO-HOLES

    MDR report key: 6376403 · Received March 3, 2017

    Report

    Report Number
    3005180920-2017-00084
    Event Type
    Malfunction
    Date Received
    March 3, 2017
    Date of Event
    February 1, 2017
    Report Date
    April 13, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    PMA / PMN Number
    K132879
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2017 THE R&D PROJECT MANAGER PERFORMED A VISUAL INSPECTION OF BOTH THE IMAGES RECEIVED AND THE RETRIEVED IMPLANTS, AND COMMENTED AS FOLLOWS: NO PARTICULAR SIGN CAN BE NOTED ON THE SHELL. SOME SHAVINGS/DEBRIS CAN BE SEEN INSIDE THE PACKAGING, IN PARTICULAR ON THE FOAM. THESE PARTICLES DETACHED FROM THE COATING. ON THE INTERNAL SURFACE OF THE BLISTER SOME SCRATCHES CAN BE NOTED. OUR TECHNICAL DIRECTOR IS IN CONTACT WITH OUR SUPPLIER OF COATING IN ORDER TO EVALUATE THE ISSUE AND DEFINE ANY POSSIBLE PREVENTIVE ACTION.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 28 FEBRUARY 2017. LOT 133658: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 FEBRUARY 2014. EXPIRATION DATE: 2019-01-31. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. DEVICE NOT YET RECEIVED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 12 APRIL 2017 FROM THE SUPPLIER OF THE COATING FOR THE SUBJECT DEVICE AND INCLUDED: THE SUBJECT DEVICE WAS COATED USING A MANUAL MACHINE AND THEN IT WAS TREATED IN ORDER TO REMOVE IRREGULARITIES IN THE COATING, WHICH COULD LEAD TO DETACHMENT. WE HAVE EVIDENCE THAT EVEN WITH A POST-TREATMENT MANUALLY IT IS POSSIBLE TO ACHIEVE GOOD RESULTS IN COATING. WE CAN THEREFORE ASSUME THAT THIS IS AN ISOLATED CASES. ALSO, THE MANUAL MACHINE IS NO MORE IN USE. IT HAS BEEN REPLACED BY AN AUTOMATIC MACHINE, WHICH GUARANTEES AN HIGHER STANDARD OF RESULT.

    Description of Event or Problem · 1

    UPON OPENING THE IMPLANT, THE SURGICAL TECH NOTICED METAL SHAVINGS/DEBRIS INSIDE THE STERILE PACKAGING. A SECONDARY IMPLANT WAS USED TO COMPLETE THE SURGERY. THERE WAS NO DELAY IN THE CASE. THE SURGERY WAS COMPLETED SUCCESSFULLY. IMPLANT IS AVAILABLE FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159568 MPACT ACETABULAR SHELL Ø46 TWO-HOLES ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 133658

    Patients

    Seq Age Sex Outcome Treatment
    1 Other