BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT MULTI HOLES SHELL

    MDR report key: 5839938 · Received August 2, 2016

    Report

    Report Number
    3005180920-2016-00417
    Event Type
    Injury
    Date Received
    August 2, 2016
    Date of Event
    July 19, 2016
    Report Date
    January 19, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 25 JULY 2016 AND INCLUDES: X-RAYS WILL NOT BECOME AVAILABLE. FURTHER DETAILS RECEIVED ON 26 JULY 2016: THE ANTIBIOTIC SPACER WAS PLACED IN FOR PREVENTATIVE PURPOSES. THE CUP, LINER AND SCREWS WERE THE ONLY MEDACTA PRODUCT REMOVED. BATCH REVIEW PERFORMED ON 02 AUGUST 2016: LOT 133726: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31 MARCH 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. MPACT FLAT PE HC LINER Ø36/F CODE 01.32.3648HCT LOT. 140553 (K103721): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 APRIL 2014. EXPIRATION DATE: 2019-02-28. 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. MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 45 CODE 01.32.6545 LOT. 115668 (K103721): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03 MAY 2012. EXPIRATION DATE: 2017-03-31. 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 20 DECEMBER 2016 AND INCLUDES: THE SURGEON REMOVED THE ANTIBIOTIC SPACER AND IMPLANTED NEW PRODUCTS ON (B)(6) 2016. ON 23 DECEMBER 2016 THE MEDICAL AFFAIRS DIRECTOR EVALUATED THE X-RAY IMAGES RECEIVED FROM THE REPORTER AND COMMENTED AS FOLLOWS: EVERYTHING SUGGESTS AN INFECTION AND THERE IS NO REASON TO SUSPECT OF DEFECTIVE DEVICES.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THERE WAS NO INFECTION. THE SURGEON NOTICED A HOLE NEAR THE INCISION SITE. THE SURGEON REVISED ALL THE IMPLANTS AND PLACED IN AN ANTIBIOTIC SPACER. THE SURGEON MADE A SKIN FLAP TO CLOSE THE HOLE. THE SURGERY WAS COMPLETED SUCCESSFULLY. EXPLANTS ARE NOT AVAILABLE DUE TO HOSPITAL POLICY. X-RAYS MAY BECOME AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491420 MPACT MULTI HOLES SHELL ACETABULAR CEMENTLESS SHELL Ø58 LPH MEDACTA INTERNATIONAL SA 133726

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention