BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK STD CEMENTED FEMUR SIZE 5 LEFT

    MDR report key: 4812197 · Received May 29, 2015

    Report

    Report Number
    3005180920-2015-00107
    Event Type
    Injury
    Date Received
    May 29, 2015
    Report Date
    September 4, 2015
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    JWH
    PMA / PMN Number
    K090988
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 05 AUGUST 2015 THE RETRIEVED ITEMS WERE INSPECTED BY THE (B)(4) WITH THE FOLLOWING COMMENT: FROM VISUAL INSPECTION OF BOTH THE TIBIAL BASEPLATE AND THE FEMUR EXPLANTED NO ANOMALIES WERE NOTED. IT WAS NOTED THAT NO RESIDUAL CEMENT WAS PRESENT IN THE CEMENTATION POCKETS. IN ONLY FEW PARTS OF THESE SURFACES SOME SIGNS WERE NOTED, PROBABLY DUE TO RESIDUAL CEMENT. THE REMAINING PART OF THE SURFACE LOOKS "CLEAN". IT IS POSSIBLE THAT IN THIS PORTION THE CEMENT DIDN'T ADHERE CORRECTLY, OR MAYBE IT WAS COMPLETELY REMOVED DURING THE WASHING PROCESS AFTER EXPLANTATION. AS DESCRIBED IN THE EVENT DESCRIPTION, CEMENT DID NOT BOND TO THE IMPLANT, NORMALLY RELATED TO THE SURGICAL TECHNIQUE. DUE TO THE LACK OF INFORMATION, IT IS NOT POSSIBLE TO IDENTIFY POSSIBLE ROOT CAUSES. ON 06 AUGUST 2015 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION COLLECTED DURING THE INVESTIGATION, ALREADY REPORTED IN THE INITIAL REPORT AND HERE ABOVE. ON 11 AUGUST 2015 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(4) 2015. LOT 112982: (B)(4) FEMURS MANUFACTURED AND RELEASED ON 08/10/2011. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. LOT 114634: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02/08/2012. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. LOT 114250: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01/12/2012. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. ON 05/12/2015 IT WAS CONFIRMED THAT NO X-RAY IS AVAILABLE. ON 05/15/2015 THE MEDICAL AFFAIRS MADE THE FOLLOWING ANALYSIS: IN THIS CASE, CEMENT DID NOT BOND TO THE IMPLANT. CEMENT IS NOT A GLUE, AND NO CHEMICAL INTERACTION SHOULD BE EXPECTED BETWEEN CEMENT AND PROSTHESIS. FOR THIS REASON, I WOULD NOT CONSIDERED ANY PARTICULAR ACTION TO BE TAKEN ON THE IMPLANT. THERE MAY BE SEVERAL REASONS WHY CEMENT DOES NOT BOND TO THE IMPLANT, AND NORMALLY THEY ARE RELATED WITH OPERATIVE TECHNIQUE. THEY INCLUDE TEMPERATURE ISSUES (E.G. COLD IMPLANTS OR UNUSUALLY WARM OP TEMPERATURE), PRESENCE OF LIQUIDS, TIMING ISSUES WHEN APPLYING CEMENT, AND SEVERAL OTHERS.

    Description of Event or Problem · 1

    IMP REF # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349900 GMK STD CEMENTED FEMUR SIZE 5 LEFT KNEE STD CEMENTED FEMUR JWH MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1