BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS

    MDR report key: 10391214 · Received August 11, 2020

    Report

    Report Number
    3004154314-2020-00004
    Event Type
    Injury
    Date Received
    August 11, 2020
    Report Date
    July 14, 2020
    Manufacturer
    ARTHROSURFACE, INC.
    Product Code
    KRR
    PMA / PMN Number
    K060127
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON INFORMATION IN THE MEDWATCH REPORT, THE PATIENT RECEIVED ONLY THE PATELLA IMPLANT OF THE PF SYSTEM DURING HER KNEE SURGERY IN 2014. THE SURGEON DID NOT USE THE ACCOMPANYING FEMORAL TROCHLEAR IMPLANT WHICH MAKES IT AN OFF-LABEL USE. HENCE, THE CURRENT COMPLICATIONS REPORTED BY THE PATIENT CANNOT BE ATTRIBUTED TO THE DEVICE IN QUESTION. THE DEVICE IFU HAS THE DESCRIPTION OF THE IMPLANT AND THE INTENDED USES OF THE PF WAVE HEMIARTHROPLASTY SYSTEM. THE DEVICE HISTORY RECORD OF THE DEVICE LOT IN QUESTION WAS REVIEWED AND NO ISSUES WERE NOTED. THE PATIENT UNDERWENT A TKR IN (B)(6) 2016 DURING WHICH ARTHROSURFACE PATELLA DEVICE WAS REMOVED. THE COMPLAINT WILL BE CONSIDERED AT THIS TIME. ANY FURTHER INFORMATION RECEIVED WILL BE REVIEWED FOR REPORTABILITY AND SUBMITTED VIA SUPPLEMENTAL MDRS.

    Description of Event or Problem · 1

    ARTHROSURFACE RECEIVED AN FDA MEDWATCH REPORT (REPORT # MW5095188) ON 08/16/2020 FILED BY A CUSTOMER WHO IS CURRENTLY EXPERIENCING ISSUES WITH HER KNEE. ACCORDING TO THE MEDWATCH REPORT, THE CUSTOMER RECEIVED A PARTIAL KNEE REPLACEMENT USING ARTHOSURFACE PF IMPLANT IN (B)(6) 2014. FROM DAY ONE OF THE SURGERY, THE PAIN INCREASED, AND THE KNEE DETERIORATED TO THE POINT IT WAS DEBILITATING. HER KNEE HAD TO BE DRAINED A FEW TIMES AS THE FLUID WAS FILLING IN THE JOINT. A SECOND SURGEON PERFORMED A KNEE ARTHROSCOPIC ABRASION ARTHROPLASTY AFTER DIAGNOSING THE PATIENT WITH INFRAPATELLAR CONTRACTURE SYNDROME (IPC). DURING A POST-OP VISIT, THE SURGEON ADVISED PATIENT THAT SHE WOULD NEED A TOTAL KNEE REPLACEMENT (TKR) IN THE NEXT 9-12 MONTHS AND THAT SHE NEEDS TO START WORKING WORK ON STRENGTHENING THE LEG IN PREPARATION FOR TKR. AFTER CONNECTING WITH A COUPLE OF PHYSICIANS RECOMMENDED BY PATELLO-FEMORAL FOUNDATION, THE PATIENT LEARNED THAT SHE DID NOT HAVE ICP AND THAT THE SHE RECEIVED ONLY THE UHMWPE PATELLAR COMPONENT OF THE ARTHROSURFACE PF IMPLANT BUT NOT THE FEMORAL TROCHLEAR COUNTERPART. THE PATIENT WAS REVISED TO A TKR SINCE 2016. HOWEVER, SHE IS STILL EXPERIENCING PAIN AND BALANCE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856414 HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS KNEE JOINT PATELLOFEMORAL POLYMER/METAL SEMI-CONSTRAINED CEMENTED PROSTHESIS KRR ARTHROSURFACE, INC. 75FC2412

    Patients

    Seq Age Sex Outcome Treatment
    1 Other