BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY TIBIAL TRAY FIXED CEMENTED # 5 R

    MDR report key: 4963988 · Received July 31, 2015

    Report

    Report Number
    3005180920-2015-00167
    Event Type
    Injury
    Date Received
    July 31, 2015
    Date of Event
    July 10, 2015
    Report Date
    October 9, 2015
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    JWH
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 12 AUGUST 2015 WE GOT DETAILS ABOUT THE REVISION SURGERY: THE SURGEON CHANGED THE PE 10MM FOR A 14MM THICKER PE. IN PER-OPERATIVE, HE SIMPLY FOUND LAXITY IN THE ANTERIOR-POSTERIOR PLANE BENDING. IN THE MEDIO-LATERAL PLANE IN EXTENSION, THE KNEE WAS STABLE. GIVEN THE YOUNG AGE OF THE PATIENT, HE PREFERRED NOT TO HINGE PROSTHESIS. THE TIBIAL TRAY LOT AND CODE HAVE BEEN CORRECTED COMPARED WITH THE INITIAL REPORT, INTO CODE 02.07.1202R / LOT 141584 BATCH REVIEW PERFORMED ON 08 SEPTEMBER 2015: LOT 141584: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 JUNE 2014. EXPIRATION DATE: 2019-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. BATCH REVIEW PERFORMED ON 11 SEPTEMBER 2015 ON THE LOT OF THE PE TIBIAL INSERT, THAT WAS THE ONLY COMPONENT EXPLANTED: LOT 131853: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 JULY 2013. EXPIRATION DATE: 2018-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. ON 11 SEPTEMBER 2015 (B)(4) MADE THE VISUAL INSPECTION OF THE RETRIEVED INSERT: FROM A VISUAL INSPECTION NO ANOMALIES HAVE BEEN NOTED ON THE INSERT. IN THE REVISION SURGERY THE THICKNESS OF THE INSERT WAS CHANGED (14MM) COMPARED TO THE ONE IMPLANTED IN THE PRIMARY SURGERY (10MM) DUE TO THE LAXITY OF THE LIGAMENTS. THE NEED OF A REVISION SURGERY WAS NOT RELATED TO THE IMPLANT.

    Additional Manufacturer Narrative · 1

    ON 17 SEPTEMBER 2015 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT AND IN THE FOLLOW UP # 1. ON (B)(4) 2015 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON JULY 31, 2015: LOT 140930: (B)(4) ITEMS MANUFACTURED AND RELEASED ON MAY 14, 2014. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ITEMS OF THE LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. ON JULY 24, 2015, THE (B)(4) CHECKED THE X-RAYS AND MADE THE FOLLOWING ANALYSIS: THE IMPLANT LOOKS PROPERLY ALIGNED AND POSITIONED. REPORTEDLY, AT REVISION A FRACTURE OF COLLATERAL LIGAMENT WAS DETECTED AND THERE IS A SUSPICION OF A BONE FRACTURE OF THE MEDIAL TIBIAL PLATEAU. THE X-RAYS ARE COMPATIBLE WITH THIS HYPOTHESIS. THE SCENARIO IS COMPATIBLE WITH A TRAUMATIC EVENT, NOT REPORTED: IT MAY WELL BE THE ROOT CAUSE FOR THE REVISION. A MISSING/BROKEN COLLATERAL LIGAMENT IMPLIES INSTABILITY OF THE ARTIFICIAL JOINT, WHICH NORMALLY NEEDS TO BE REPLACED WITH A CONSTRAINED PROSTHESIS.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498907 GMK PRIMARY TIBIAL TRAY FIXED CEMENTED # 5 R FIXED CEMENTED TIBIAL TRAY JWH MEDACTA INTERNATIONAL, SA 131853

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention