BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY CEMENTED PS FEMUR SIZE 3 RIGHT., NARROW

    MDR report key: 5087202 · Received September 18, 2015

    Report

    Report Number
    3005180920-2015-00197
    Event Type
    Injury
    Date Received
    September 18, 2015
    Date of Event
    August 20, 2015
    Report Date
    December 14, 2015
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K122232
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 15 SEPTEMBER 2015. GMK-PRIMARY 02.07.2213R FEMUR CEMENTED PS #3NARROW / RIGHT LOT. 131961 LOT 131961: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 MAY 2013. EXPIRATION DATE: 2018-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-PRIMARY 02.07.1203R TIBIAL TRAY FIXED CEMENTED # 3 R LOT. 130226 (K090988): LOT 130226: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 MAR 2013. EXPIRATION DATE: 2018-02-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ON 05 SEPTEMBER 2015 THE MEDICAL AFFAIRS DIRECTOR MADE THE FOLLOWING ANALYSIS: IN SPITE OF THE POOR QUALITY RADIOGRAPHS, SIGNS OF LOOSENING CAN BE SEEN, PARTICULARLY ON FEMORAL COMPONENT. THE BONE MORPHOLOGY OF THIS PATIENT IS VERY PECULIAR AND THE OPERATION WAS PROBABLY RATHER DEMANDING, BUT THE PROSTHESIS APPEARED TO HAVE BEEN IMPLANTED CORRECTLY. ACCORDING TO THE REPORT, PICTURES OF THE EXPLANTS OR THE EXPLANTS THEMSELVES MIGHT BE DELIVERED TO US IN ORDER TO FURTHER THIS INVESTIGATION, IF THE SURGEON THINKS THAT THIS IS APPROPRIATE. AT THIS STAGE, I CAN DRAW NO DEFINITE CONCLUSION AS TO THE ROOT CAUSE FOR LOOSENING. IT LOOKED LIKE THE FIXATION DEFECT WAS BETWEEN CEMENT AND BONE. ON 18 SEPTEMBER 2015 THE R&D PROJECT MANAGER CHECKED THE RETRIEVED IMPLANTS WITH THE FOLLOWING ANALYSIS: FROM A VISUAL INSPECTION OF BOTH TIBIAL BASEPLATE AND FEMUR COMPONENT EXPLANTED, NO ANOMALIES HAVE BEEN NOTED. NO RESIDUAL CEMENT WAS PRESENT IN THE CEMENTATION POCKETS OF THE IMPLANTS EXPLANTED. FROM WEAR ANALYSIS, IT SEEMS THAT THE IMPLANT WAS CORRECTLY POSITIONED. DUE TO THE LACK OF INFORMATION, IT IS NOT POSSIBLE TO IDENTIFY POSSIBLE ROOT CAUSES. USUALLY THIS KIND OF EVENT ARE CAUSED BY THE CEMENT THAT DID NOT BOND TO THE IMPLANT OR TO THE BONE. THIS IS NORMALLY RELATED TO THE SURGICAL TECHNIQUE AND NOT TO THE IMPLANT.

    Additional Manufacturer Narrative · 1

    ON 16 NOV 2015 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON 18 NOV 2015 IT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    THE PATIENT WAS COMPLAINING OF PAIN SO THE SURGEON DECIDED TO REVISE THE TKA. INTRAOPERATIVELY, THE SURGEON NOTICED THE CEMENTED COMPONENTS HAD COME LOOSE. ALL THE ORIGINAL COMPONENT WERE REMOVED AND REPLACED WITH REVISION COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618282 GMK PRIMARY CEMENTED PS FEMUR SIZE 3 RIGHT., NARROW CEMENTED PS FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 131961

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention