BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H CEMENTLESS STEM SIZE 5 LAT

    MDR report key: 5323066 · Received December 23, 2015

    Report

    Report Number
    3005180920-2015-00355
    Event Type
    Injury
    Date Received
    December 23, 2015
    Date of Event
    November 18, 2015
    Report Date
    March 30, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 01 MARCH 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT.ON 02 MARCH 2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2015 IT WAS COMMUNICATED THAT THE PATHOGEN IS NOT KNOWN. BATCH REVIEW PERFORMED ON 21 DECEMBER 2015: LOT. 141480: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02 JUNE 2014. EXPIRATION DATE: 2019-04-30. 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. OTHER COMPONENTS: COCR BALL HEAD 12/14 Ø 36 SIZE XL CODE 01.25.033 LOT. 112919 ((B)(4)): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 SEPTEMBER 2011. EXPIRATION DATE: 2016-08-31. 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 HOODED PE HC LINER Ø36/F CODE 01.32.3648HCAT LOT. 134708 ((B)(4)): 45 ITEMS MANUFACTURED AND RELEASED ON 13 JANUARY 2014. EXPIRATION DATE: 2018-11-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 14 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. MPACT ACETABULAR SHELL Ø56 CODE 01.32.156DH LOT. 135868 ((B)(4)): (B)(4 )ITEMS MANUFACTURED AND RELEASED ON 19 MAY 2014. EXPIRATION DATE: 2019-04-30. 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. TWO OUT OF THE FOLLOWING THREE SCREWS WERE IMPLANTED, BUT IT IS NOT CONFIRMED EXACTLY WHICH OF THEM: MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 30; CODE 01.32.6530 LOT. 130452 ((B)(4)): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 MARCH 2013. EXPIRATION DATE: 2018-01-31. 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 CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 35; CODE 01.32.6535 LOT. 115666 ((B)(4)): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 APRIL 2012. EXPIRATION DATE: 2017-02-28. 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 CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 40; CODE 01.32.6540 LOT. 115667 ((B)(4)): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08 MAY 2012. 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 WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF HIP PAIN. THE SURGEON DETERMINED THAT THE PATIENT HAD AN INFECTION. ON (B)(6) 2015 THE SURGEON REMOVED ALL COMPONENTS AND PUT IN ANTIBIOTIC SPACERS.ON (B)(6) 2015 THE SURGEON PUT A 54 MM CUP WITH NEW ANTIBIOTIC SPACERS. THE EXPLANTS WILL NOT BE RETURNED. THERE ARE NO X-RAYS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847166 AMISTEM H CEMENTLESS STEM SIZE 5 LAT CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 141480

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention