BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H, HA COATED STEM SIZE 6 STD

    MDR report key: 6079081 · Received November 4, 2016

    Report

    Report Number
    3005180920-2016-00567
    Event Type
    Injury
    Date Received
    November 4, 2016
    Date of Event
    October 6, 2016
    Report Date
    November 4, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 18 OCTOBER 2016 AND INCLUDES: THE PATIENT TESTED POSITIVE FOR SERATIA MARCESANS. BATCH REVIEWS PERFORMED ON 03 NOVEMBER 2016. LOT 150861: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 JUNE 2015. EXPIRATION DATE: 2020-04-30. 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. VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 52, CODE 01.26.45.0052, LOT. 151399 (K103352) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 JUNE 2015. EXPIRATION DATE: 2020-05-31. 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. MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0, CODE 01.29.209, LOT. 148661 (K112115) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 MARCH 2015. EXPIRATION DATE: 2020-01-31. 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. VERSAFITCUP FLAT PE HC LINER Ø 36 / E, CODE 01.26.3644HCT, LOT. 152088 (K120531) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03 AUGUST 2015. EXPIRATION DATE: 2020-06-30. 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. VERSAFITCUP CANCELLOUS BONE SCREW FLAT HEAD Ø 6,5 L 45, CODE 01.26.65.45, LOT. 135327 (K103352) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 FEBRUARY 2014. EXPIRATION DATE: 2018-12-31. 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. ON 04 NOVEMBER 2016, THE (B)(4) PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: SECOND INFECTION ON A THA PATIENT. REITERATE INFECTIONS ARE UNFORTUNATELY A POSSIBLE ADVERSE EVENT FOLLOWING JOINT ARTHROPLASTY. THERE IS NO REASON TO SUSPECT THAT A DEFECTIVE IMPLANT CAUSED THIS PROBLEM.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE SURGEON REVISED THE HEAD, STEM, LINER CUP AND SCREWS. THE SURGEON IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE AVAILABLE. EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729356 AMISTEM H, HA COATED STEM SIZE 6 STD CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 150861

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention