BEUDAMED
    FDA Adverse Event Summary report: N

    HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS

    MDR report key: 5225521 · Received November 16, 2015

    Report

    Report Number
    3004154314-2014-00004
    Date Received
    November 16, 2015
    Date of Event
    April 8, 2014
    Report Date
    October 26, 2015
    Manufacturer
    ARTHROSURFACE
    Product Code
    KRR
    PMA / PMN Number
    K060127
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS LEARNED THAT THE PATIENT WAS NOT COMPLAINING SPECIFICALLY ABOUT THE HEMICAP PRODUCT BUT RATHER LOOKING FOR OTHER OPTIONS THEY COULD PURSUE INSTEAD OF A TOTAL KNEE IMPLANT. PATIENT HAS HAD 30 PREVIOUS KNEE SURGERIES AND THEREFORE, IT CANNOT BE ASSUMED THAT THE HEMICAP PRODUCT WAS CONTRIBUTING TO THE ISSUE. ARTHROSURFACE, INC'S CLINICAL AND SCIENTIFIC ADVISOR CONTACTED THE PATIENT TO DISCUSS FUTURE OPTIONS FROM THEM, BUT NEVER RECEIVED A RESPONSE. NO FURTHER ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINT RECORD WAS OPENED WHEN THE PATIENT'S SECOND EMAIL CAME IN ON THE (B)(6) 2014. PRIOR TO THIS, NOT ENOUGH INFORMATION WAS AVAILABLE TO DETERMINE IF THE EMAIL WAS A COMPLAINT. THE PATIENT COMPLAINED ABOUT THE POST OPERATIVE COMPLICATIONS THAT SHE WAS HAVING AFTER BEING IMPLANTED WITH HEMICAP PF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755252 HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER KRR ARTHROSURFACE PX11-9218/ PX02-0852/ P306-0090 75CC0617, 75FB1506, 75LJ2217

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other