BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SHELL Ø54 TWO-HOLES

    MDR report key: 5830064 · Received July 28, 2016

    Report

    Report Number
    3005180920-2016-00407
    Event Type
    Injury
    Date Received
    July 28, 2016
    Date of Event
    July 12, 2016
    Report Date
    July 28, 2016
    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

    THIS IS THE SECOND REVISION SURGERY UNDERWENT BY THE PATIENT. THE PATIENT HAD PREVIOUSLY CAME IN DUE TO INSTABILITY. THE SURGEON NOTICED THE STEM WAS SUBSIDING AND REVISED THE STEM AND HEAD ON (B)(6) 2015. (MDR (B)(4)). ADDITIONAL INFORMATION RECEIVED ON 14 JULY 2016 AND INCLUDES: CONFIRMED PATHOGEN ENTEROCOCCUS. ADDITIONAL INFORMATION RECEIVED ON 21 JULY 2016 AND INCLUDES: ALL THE LISTED MEDACTA COMPONENTS WERE EXPLANTED: CUP, BALL HEAD, LINER, SCREW. BATCH REVIEWS PERFORMED ON 27 JULY 2016. LOT 132047: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 DECEMBER 2013. EXPIRATION DATE: 2018-07-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. COCR BALL HEAD 12/14 Ø 32 SIZE S -3.5, CODE 01.25.021, LOT. 147309 (K072857), (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 FEBRUARY 2015. EXPIRATION DATE: 2019-12-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. MPACT FLAT PE HC LINER Ø 32/E, CODE 01.32.3244HCT, LOT. 132128 (K103721), (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 JULY 2013. EXPIRATION DATE: 2018-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 40, CODE 01.32.6540, LOT. 115667 (K103721), (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08 MAY 2011. EXPIRATION DATE: 2017-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH TWO SIMILAR REPORTED EVENTS (MDRS 2016-00175 AND 2016-00359). NOT AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482585 MPACT ACETABULAR SHELL Ø54 TWO-HOLES ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 132047

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention