BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM C, CEMENTED STEM SIZE 0 STD

    MDR report key: 6249496 · Received January 13, 2017

    Report

    Report Number
    3005180920-2016-00740
    Event Type
    Injury
    Date Received
    January 13, 2017
    Date of Event
    December 16, 2016
    Report Date
    April 13, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K103189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 16 MARCH 2017 AND INCLUDES: ON THE CONTRARY OF WHAT WAS PREVIOUSLY REPORTED, THE PIECES ARE NOT AVAILABLE FOR FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THIS IS THE SECOND REVISION SURGERY UNDERWENT BY THE PATIENT. THE PATIENT HAD A PRIMARY HIP ON (B)(6) 2012. ON (B)(6) 2014 THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THAT THE STEM WAS POTTED. THE SURGEON REVISED THE STEM, HEAD AND LINER. ON (B)(6) 2017 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AN D COMMENTED AS FOLLOWS: TWO YEARS AFTER HYBRID THA, WHICH CAME AS A PARTIAL REVISION OF PREVIOUS CEMENTLESS THA, THIS YOUNG FEMALE PATIENT COMPLAINED OF HIP PAIN AND WAS REVISED AGAIN. ONLY ONE INTRAOPERATIVE IMAGE IS AVAILABLE, AND NO INDICATIONS AS TO THE POSSIBLE CAUSE OF PAIN CAN BE DRAWN FROM THERE. THERE ARE NO OTHER INDICATIONS THAT CAN HELP UNDERSTANDING THE ETIOLOGY OF THE PROBLEM. BATCH REVIEWS PERFORMED ON 09 JANUARY 2017. LOT 131652: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27 JUNE 2013. EXPIRATION DATE: 2018-04-30. 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. MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0, CODE 01.29.202, LOT. 141151 (K112115). (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17 JUNE 2014. EXPIRATION DATE: 2019-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. DOUBLE MOBILITY HC LINER Ø 48/28, CODE 01.26.2848MHC, LOT. 141721 (K092265). (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16 JUNE 2014. EXPIRATION DATE: 2.019-04-30. 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 ACETABULAR SHELL Ø 48, CODE 01.26.48MB, LOT. 122047 (K083116) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31 AUGUST 2012. EXPIRATION DATE: 2017-07-31. 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. NOT YET RECEIVED.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF HIP PAIN. THE CAUSE OF PAIN IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA PRODUCTS. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33900 AMISTEM C, CEMENTED STEM SIZE 0 STD CEMENTED FEMORAL STEM JDI MEDACTA INTERNATIONAL SA 131652

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention