BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H, HA COATED STEM SIZE 6 STD

    MDR report key: 7032793 · Received November 15, 2017

    Report

    Report Number
    3005180920-2017-00659
    Event Type
    Injury
    Date Received
    November 15, 2017
    Date of Event
    October 16, 2017
    Report Date
    November 15, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804120
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE SECOND REVISION SURGERY UNDERWENT BY THE PATIENT. THE PATIENT HAD A PRIMARY HIP IN (B)(6) 2017. IN (B)(6) L 2017 THE SURGEON REVISED THE PATIENT DUE TO AN INFECTION (PATHOGEN CONFIRMED AS E. COLI). THE SURGEON WASHED OUT THE PATIENT AND REVISED THE HEAD AND LINER. THEN, IN (B)(6) 2017 THE PATIENT FELL AND CAME IN COMPLAINING OF PAIN. ON(B)(6) 2017 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: SIX MONTHS AFTER REVISION SURGERY, TOTAL HIP RE-REVISION IS REQUIRED. RADIOGRAPHIC IMAGE SHOWS THE PRESENCE OF A MOBILIZED CUP CAUSED BY A TRAUMATIC EVENT. THE INITIAL POSITION OF THE CUP CANNOT BE ASSESSED HAVING ONLY ONE POST-TRAUMATIC X-RAYS. ON THE BASIS OF AVAILABLE DATA, THERE IS NO REASON TO SUSPECT A FAULTY DEVICE. BATCH REVIEWS PERFORMED ON 13 NOVEMBER 2017. LOT 164614: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09 NOVEMBER 2016. EXPIRATION DATE: 2021-10-30. 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 L +3.5, CODE 01.29.203, LOT. 163448 (K112115) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 OCTOBER 2016. EXPIRATION DATE: 2021-09-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE,(B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD AND THIS IS THE SECOND SIMILAR EVENT REPORTED ON THE LOT. VERSAFITCUP ACETABULAR SHELL Ø 52, CODE 01.26.52MB, LOT. 161582 (K083116) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09 NOVEMBER 2016. EXPIRATION DATE: 2021-10-30. 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 DOUBLE MOBILITY HC LINER Ø 52/28, CODE 01.26.2852MHC, LOT. 162321 (K092265) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 JULY 2016. EXPIRATION DATE: 2021-06-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD AND THIS IS THE SECOND SIMILAR EVENT REPORTED ON THE LOT.

    Description of Event or Problem · 1

    THE PATIENT FELL AND CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THE CUP WAS KNOCKED LOOSE WITH THE FALL. THE SURGEON ALSO DETERMINED THAT THE PATIENT WAS INFECTED. THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812044 AMISTEM H, HA COATED STEM SIZE 6 STD CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 164614 07630030804120

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention