BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY FIXED PS TIBIAL INSERT SIZE 5 / 14 MM

    MDR report key: 5034443 · Received August 27, 2015

    Report

    Report Number
    3005180920-2015-00180
    Event Type
    Injury
    Date Received
    August 27, 2015
    Date of Event
    July 28, 2015
    Report Date
    November 18, 2015
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 26 AUGUST 2015: LOT 121583: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01 JUNE 2012. EXPIRATION DATE: 2017-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. ADDITIONAL INFORMATION RECEIVED BY EMAIL ON 25TH AUGUST 2015 FROM MEDACTA USA: " THE SURGEON WHO CONDUCTED THE REVISION IS NOT A MEDACTA SURGEON. THEIR ONE AND ONLY CASE IN THE SYSTEM WAS THIS POLY EXCHANGE. I DON'T KNOW WHEN THEY WERE MADE AWARE THAT A REVISION WAS NEEDED. I CAN ASK THE SALES AGENT IF HE HAS ANY EMAIL CORRESPONDENCE. I WILL KEEP YOU INFORMED." ON THE SAME DATE THE AGENT - NOT A MEDACTA EMPLOYEE - WROTE THE FOLLOWING: " IT'S BEEN AWHILE SINCE THIS CASE TOOK PLACE. FROM WHAT I CAN REMEMBER IT WAS A LAST SECOND ADD ON AND WE RAN IMPLANTS AND INSTRUMENTS DOWN AND A SIMPLE POLY EXCHANGE WAS PERFORMED. I AM USUALLY VERY GOOD AT INFORMING THE COMPANIES I WORK WITH ABOUT REVISION CASES. IF THIS IS ONE I MISSED I APOLOGIZE " ON 25 AUGUST THE MEDICAL AFFAIRS DIRECTOR ADDED THE FOLLOWING COMMENTS ON THE CASE: IT IS HARD TO SAY SOMETHING: THE FACT THAT THE ONLY IMPLANT REVISED WAS THE INSERT LEADS ME TO THINK THAT: THERE WERE NO SIGNS OF INFECTION, NO MOBILIZATION, NO MALPOSITIONING, NO LOCAL REACTIONS DUE TO FOREIGN BODY PRESENCE, NO PROBLEMS OF CONGRUENCY BETWEEN THE ARTICULAR SURFACES, NO MECHANICAL PROBLEMS TO THE IMPLANTED DEVICES, NO UNEXPECTED WEAR. IF ALL THE SURGEONS CONTACTED BY THE PATIENT WERE NOT ABLE TO EXPLAIN THE ORIGIN OF THE PROBLEM, BEING ABLE TO VISIT HIM AND TO HAVE ALL THE POSSIBLE INFORMATION AND ANALYSIS, IT IS IMPOSSIBLE FOR ME TO ADD MORE, WITHOUT HAVING NONE OF THOSE ELEMENTS AT DISPOSAL.

    Additional Manufacturer Narrative · 1

    ON 20 OCTOBER 2015 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INTIAL REPORT. ON 27 OCT 2015 THE FINAL REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    ON 07/28/2015 FDA ISSUED THE ATTACHED LETTER TO MEDACTA USA INFORMING ABOUT THE EXISTENCE OF A VOLUNTARY REPORT - NUMBER MW5043220 - OF WHICH WE WERE NOT AWARE. AS REPORTED IN THE REPORT SENT TO FDA BY THE PATIENT:" I HAD A TOTAL KNEE REPLACEMENT 2012. SINCE THAT TIME, I HAVE EXPERIENCED NOTHING BUT PAIN AND FLUID ON MY RIGHT KNEE WHICH IS DEBILITATING, I HAD A SECOND SURGERY FOR HEMORRHAGING, BUT I STILL CONTINUED WITH THE PROBLEM OF DEBILITATING PAIN. AT THE TIME OF THE SECOND SURGERY; I WAS TOLD THAT I MIGHT HAVE A BLEEDING DISORDER. THIS COMMENT WAS FOLLOWED BY BLOOD TESTS AND THE TESTS DID NOT SUBSTANTIATE THAT DIAGNOSIS. I HAVE HAD NUMEROUS TESTS AND CONSULTS BY 3 DIFFERENT ORTHOPEDIC SURGEONS. ONE OF THE CONSULTS RESULTED IN ANOTHER SURGERY . THERE WAS SOME RETAINED CARTILAGE. THIS DID DECREASE THE CONTINUOUS PAIN WHICH IS ALMOST NOT BEARABLE. NOT ONE MD HAS BEEN ABLE TO EXPLAIN TO ME WHY I HAVE THE COPIOUS AMOUNTS OF FLUID. IF THAT WAS NOT PRESENT, I THINK I WOULD BE ABLE TO FUNCTION. STILL HAVING NO ANSWER, I HAVE BEGUN LOOKING AT POSSIBLE OTHER CAUSES, I.E., POTENTIAL RECALLS. THE ACTUAL IMPLANT WAS TIBIAL INSERT PS FIXED SA % 14 MM RIGHT MATERIAL PE TYPER 1 PS 02.07.0514PSF LOT NUMBER WAS 121583. CATALOGUE NUMBER WAS 02.07.1205R MANUFACTURER WAS MEDACTA. I CONTINUE TO SEARCH FOR ANSWERS THAT THOUGHT THERE MIGHT BE OTHER SIMILAR REPORTS ON THE ABOVE REFERENCED PRODUCT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568112 GMK PRIMARY FIXED PS TIBIAL INSERT SIZE 5 / 14 MM PE POSTERO STABILIZED KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 121583

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention