BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER HEAD BIOLOX OPTION Ø 36

    MDR report key: 5915951 · Received August 30, 2016

    Report

    Report Number
    3005180920-2016-00438
    Event Type
    Injury
    Date Received
    August 30, 2016
    Date of Event
    August 1, 2016
    Report Date
    August 30, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K131518
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE THIRD REVISION SURGERY UNDERWENT BY THE PATIENT. THE PRIMARY SURGERY TOOK PLACE ON (B)(6) 2013. THE PATIENT UNDERWENT THE FIRST REVISION SURGERY ON (B)(6) 2016 DUE TO PSOAS PAIN. CUP, LINER AND HEAD WERE REPLACED. THE SECOND REVISION SURGERY TOOK PLACE ON (B)(6) 2016 DUE TO ANTERIOR DISLOCATION. POSTERIOR APPROACH WAS USED FOR ALL REVISIONS ON THIS PATIENT. ADDITIONAL INFORMATION RECEIVED ON 04 AUGUST 2016 AND INCLUDES: THE CUP INVOLVED AND REPLACED DURING THE SECOND REVISION SURGERY WAS A NON-MEDACTA PRODUCT, THE HEAD WAS MEDACTA BRANDED. ALSO, THE CUP AND LINER REMOVED AND REPLACED IN THE THIRD REVISION WERE NON-MEDACTA IMPLANTS. BATCH REVIEWS PERFORMED ON 30 AUGUST 2016. LOT 131061: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01 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. MECTACER OPTION SLEEVE SIZE L, CODE 01.29.242A, LOT. 142135 (K131518) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 JULY 2015. EXPIRATION DATE: 2020-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 3 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION DUE TO POSTERIOR DISLOCATION. LINER, HEAD AND SLEEVE REPLACED. NO X-RAYS OR EXPLANTS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566389 MECTACER HEAD BIOLOX OPTION Ø 36 CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 131061

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention