BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 3+ LEFT

    MDR report key: 6063485 · Received October 28, 2016

    Report

    Report Number
    3005180920-2016-00551
    Event Type
    Injury
    Date Received
    October 28, 2016
    Date of Event
    September 27, 2016
    Report Date
    October 28, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE SECOND REVISION SURGERY UNDERWENT BY THIS PATIENT. THE PATIENT HAD A PRIMARY BILATERAL KNEE ON ( (B)(6) 2016. THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE SURGEON SWAPPED THE POLY (B)(4). THEN, THE PATIENT CAME AGAIN IN DUE TO SIGNS OF INFECTION. THE SURGEON REMOVED ALL MEDACTA HARDWARE AND INPUT AN ANTIBIOTIC SPACER. THE DATE IN WHICH MEDACTA PRODUCT WAS REMOVED IS UNKNOWN. THE PATIENT TESTED POSITIVE FOR ENTEROBACTER CLOACAE. ON (B)(6) 2016 THE SURGEON IMPLANTED PERMANENT HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY. BATCH REVIEWS PERFORMED ON 28 OCTOBER 2016. LOT 140525: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23 MAY 2014. EXPIRATION DATE: 2019-01-31. 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. GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T4-I3 LEFT, CODE 02.12.T4I3L, LOT. 131499 (K121416) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 SEPTEMBER 2013. EXPIRATION DATE: 2018-07-31. 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. GMK-SPHERE PATELLA RESURFACING SIZE 2, CODE 02.07.0034RP, LOT. 150323 (K090988) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 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. GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 3/12 MM LEFT, CODE 02.12.0312FL, LOT. 132938 (K121416) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24 JULY 2013. EXPIRATION DATE: 2018-06-30. 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. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE SURGEON REMOVED ALL MEDACTA HARDWARE AND INPUT AN ANTIBIOTIC SPACER. THE PATIENT TESTED POSITIVE FOR ENTEROBACTER CLOACAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716692 GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 3+ LEFT FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 140525

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention