BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLIDING CORE UHMPWE, 6MM

    MDR report key: 5984160 · Received September 28, 2016

    Report

    Report Number
    0008031020-2016-00490
    Event Type
    Injury
    Date Received
    September 28, 2016
    Date of Event
    September 12, 2016
    Report Date
    January 6, 2017
    Manufacturer
    STRYKER GMBH
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. THE REPORTED DEVICE WAS MANUFACTURED AND DISTRIBUTED BY SMALL BONE INNOVATION, INC., (B)(4) AND IMPLANTED PRIOR TO HOWMEDICA OSTEONICS CORP.¿S PURCHASE OF CERTAIN ASSETS OF SBI ON AUGUST 1, 2014. STRYKER BECAME LEGAL MANUFACTURER OF THIS PRODUCT ON APRIL 1, 2015 AND HAS TAKEN THE RESPONSIBILITY FOR MEDICAL DEVICE REPORTING.

    Additional Manufacturer Narrative · 1

    EVALUATION REVEALED THE SLIDING CORE UHMPWE 6MM TO BE THE SUBJECT PRODUCT. NO FURTHER ASSOCIATED PRODUCTS WERE REPORTED. THE AFFECTED ITEM WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. THUS, WE EXCLUDED DEVIATIONS IN MATERIAL AND MANUFACTURING. DURING INVESTIGATION NO MATERIAL, DESIGN OR MANUFACTURING RELATED ISSUES WERE FOUND. IN THE CASE PRESENTED A PATIENT HAD BEEN TREATED WITH STAR ON (B)(6) 2012 DUE TO A RIGHT ANKLE TRAUMATIC ARTHROPATHY. AFTER AN IMPLANTATION PERIOD OF 4 YEARS, THE PATIENT RETURNED TO THE HOSPITAL AS HE WAS EXPERIENCING PAIN. THE ATTENDING PHYSICIAN DIAGNOSED A SIGNIFICANT SWELLING IN HIS RIGHT ANKLE. HIS IMPLANT COMPONENTS LOOKED OKAY. LYSIS UNDERNEATH THE FRONT OF HIS TALUS AND MEDIALLY IN THE MALLEOLUS WAS FURTHERMORE DETECTED. THE PATIENT WAS REVISED ON (B)(6) 2016. A CURETTAGE AND GRAFTING OF THE LYSIS HAD BEEN CARRIED OUT. THE POLYETHYLENE SLIDING CORE WAS EXCHANGED. THE RETURNED SLIDING CORE WAS RECEIVED IN A VERY GOOD CONDITION. THE EXPLANT SHOWED TRACES OF MINOR WEAR, IN PARTICULAR AT THE EDGES AND THE CORNERS, BUT THERE WAS NO SIGNIFICANT DAMAGE, WEAR OR BREAKAGE. LYSIS IN GENERAL HAD BEEN EXPERIENCED AND IS NOMINATED IN THE SCIENTIFIC LITERATURE. IT DOES NOT PRESENT AN UNANTICIPATED EVENT IN ITSELF. ¿THE BYPRODUCTS OF FRICTIONAL WEAR BETWEEN THE METAL AND POLYETHYLENE COMPONENTS OF JOINT REPLACEMENTS LEAD TO PERIPHRASTIC BONE RESORPTION. THIS PROCESS IS NAMED OSTEOLYSIS AND CAN RESULT IN SUBCLINICAL OR SIGNIFICANT BONE LOSS, LOSS OF IMPLANT STABILITY, SUBSIDENCE, AND IMPLANT FAILURE¿ ¿EARLY RECOGNITION, MONITORING, AND TREATMENT OF PROGRESSIVE PERIPHRASTIC OSTEOLYSIS MAY PREVENT LOSS OF IMPLANT STABILITY¿DEBRIDEMENT OF THE CYST AND GRAFTING, CORRECTION OF MALALIGNMENT IF PRESENT, AND POLYETHYLENE EXCHANGE MAY ARREST PROGRESSIVE OSTEOLYSIS AND SHOULD BE PERFORMED BEFORE IMPLANT FAILURE.¿ THE RECEIVED X-RAYS AND MEDICAL RECORDS WERE FURTHERMORE FORWARDED TO A CONSULTANT HCP, WHO STATED [EXCERPTS]: THERE ARE LARGE LYTIC CAVITIES AROUND THE COMPONENTS ANTERIORLY IN THE TALUS AND MEDIALLY IN THE DISTAL TIBIA. THE PRECISE PATHOGENESIS OF OSTEOLYSIS REMAINS UNCLEAR, BUT BOTH BIOLOGICAL AND MECHANICAL FACTORS APPEAR TO CONTRIBUTE TO OSTEOLYSIS. I DO NOT ATTRIBUTE OSTEOLYSIS TO THE POLYETHYLENE, BECAUSE OF THE POLYETHYLENE INLAYS APPEAR INTACT WITH NO SIGNIFICANT DAMAGE. CLASSICALLY, PERI-PROSTHETIC OSTEOLYSIS IS A MANIFESTATION OF AN ADVERSE CELLULAR RESPONSE TO WEAR PARTICLES, BUT SINCE THE INLAY IS INTACT, I DOUBT THIS IS THE CAUSE. I REALIZE THE SURGEON STATES THAT THE ¿POLY LOOKS AWFULLY THIN¿, BUT I BELIEVE HE IS LOOKING AT THE RADIOGRAPHS; I FIND IT DIFFICULT TO DETERMINE THAT THE POLY IS THIN AND WITH THE EXPLANTATION, IT APPEARS NORMAL. STRESS SHIELDING MAY ALSO PARTICIPATE IN THE FORMATION OF CYSTS, DUE TO THE DIFFERENCE IN ELASTIC MODULUS BETWEEN BONE AND IMPLANT. BASED ON THE ABOVE A DEFICIENCY OF THE DEVICE IN QUESTION WAS NOT VERIFIED. OSTEOLYSIS AND/OR OTHER PERIPROSTHETIC BONE LOSS ARE KNOWN COMPLICATIONS AND ARE LISTED IN THE IFU AS POTENTIAL ADVERSE EFFECTS.

    Description of Event or Problem · 1

    RECENTLY DEVELOPED SWELLING AFTER WALKING ON UNEVEN GROUND. X-RAYS SHOWED LYSIS ON TALUS AND MEDIAL MALLEOLUS. CURRETTAGE LYSIS AND BACK FILLED WITH HA. DID MOBILE BEARING EXCHANGE.

    Description of Event or Problem · 1

    RECENTLY DEVELOPED SWELLING AFTER WALKING ON UNEVEN GROUND. X-RAYS SHOWED LYSIS ON TALUS AND MEDIAL MALLEOLUS. CURRETTAGE LYSIS AND BACK FILLED WITH HA. DID MOBILE BEARING EXCHANGE. NEW INFORMATION: IT WAS REPORTED THAT "REVISION REASON: ANKLE PAIN/LYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635879 SLIDING CORE UHMPWE, 6MM PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME NTG STRYKER GMBH 1036027

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention