BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL COMP,SINGLECOATED US VERSION, MEDIUM

    MDR report key: 5606308 · Received April 25, 2016

    Report

    Report Number
    0008031020-2016-00213
    Event Type
    Injury
    Date Received
    April 25, 2016
    Date of Event
    June 1, 2008
    Report Date
    April 1, 2016
    Manufacturer
    STRYKER GMBH
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    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 (B)(4) AND IMPLANTED PRIOR TO HOWMEDICA OSTEONICS CORP.¿S PURCHASE OF CERTAIN ASSETS OF (B)(4) ON (B)(4) 2014. STRYKER BECAME LEGAL MANUFACTURER OF THIS PRODUCT ON APRIL 1, 2015 AND HAS TAKEN THE RESPONSIBILITY FOR MEDICAL DEVICE REPORTING. AT THIS TIME, IT CANNOT BE DETERMINED WHICH IF ANY OF THE DEVICES IN THIS EVENT MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENTS' EXPERIENCE THEREFORE, THE PRODUCT INFORMATION WILL BE REFERENCED. ADDITIONAL DEVICES LISTED IN THIS REPORT: CATALOG # UNKNOWN STAR MENISICAL BEARING SURFACE: 9MM LOT# 0050073; CATALOG # UNKNOWN STAR TALAR COMPONENT: SMALL LOT# 000210-2309, DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES LISTED IN THIS REPORT: CATALOG # 400143 STAR MENISCAL BEARING SURFACE: 9MM LOT# 0050073. CATALOG # 400255 STAR TALAR COMPONENT: SMALL LOT# 000210-2309. EVALUATION REVEALED THE TIBIAL COMP, SINGLECOATED US VERSION, MEDIUM, THE SLIDING CORE UHMPWE, 9MM AND THE TALAR COMP,SINGLE COATED US VERS SMALL, LEFT TO BE THE SUBJECT PRODUCTS. NO FURTHER ASSOCIATED PRODUCTS WERE REPORTED. A PHYSICAL EXAMINATION COULD NOT BE CARRIED OUT AS THE DEVICES WERE NOT RETURNED FOR EVALUATION. THE AFFECTED ITEMS WERE 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) 2005. ON (B)(6) 2009 THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO PERSISTENT PAIN. RADIOGRAPHIC EXAMINATION SHOWED EVIDENCES OF AN OSTEOLYSIS AND A COLLAPSE. FURTHERMORE A CYSTIC DEFECT WAS IDENTIFIED IN THE TALUS BELOW THE PROSTHESIS. DURING REVISION SURGERY THE TIBIAL COMPONENT AND THE SLIDING CORE WERE FOUND TO BE LOOSENED. BONE INGROWN WAS FOUND ON THE TALAR COMPONENT. ALL IMPLANTS WERE REMOVED. THE CYSTIC DEFECT WAS REMOVED AND TREATED BY BONE GRAFT. AN ANKLE ARTHRODESIS HAD BEEN CARRIED OUT. CYST FORMATION AND OSTEOLYSIS IN GENERAL HAD BEEN EXPERIENCED AND ARE 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 PERI-PROSTHETIC 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 PERI-PROSTHETIC 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.¿ CYSTS WERE FURTHERMORE CLINICALLY ASSESSED BY A HCP: ¿CYST FORMATION IS A TYPICAL COMPLICATION OF ANKLE ARTHROPLASTY AND PROBABLY CAUSED BY BONE MODELLING ACCORDING TO THE FLUX OF FORCE INSIDE THE BONE STRUCTURE RELATED TO THE IMPLANT CONTACT.¿ ¿SPONTANEOUS BONE RESORPTION AND CYST FORMATION REPRESENTS A SIGNIFICANT PROBLEM IN ANKLE ARTHROPLASTY. THE SYMPTOMS MAY BE MILD AND WILL NOT REQUIRE SPECIFIC SURGICAL MEASURES, BUT IN MANY CASES REVISION SURGERY WITH BONE GRAFTING MAY BE REQUIRED. IN ADVANCED CASES CYST FORMATION MAY CAUSE A COLLAPSE OF THE ARTHROPLASTY REQUIRING IMPLANT REMOVAL AND ANKLE FUSION.¿ BASED ON THE ABOVE INFORMATION, A DEFICIENCY OF THE DEVICES IN QUESTIONS WAS NOT VERIFIED. NEVERTHELESS AS THE EXACT CAUSE OF OSTEOLYSIS IS STILL POORLY EXPLAINED / UNDERSTOOD AND PROBABLY MULTIFACTORIAL, A CORRELATION BETWEEN IMPLANTS AND OSTEOLYSIS COULD NOT BE EXCLUDED. IN CASE ANY RELEVANT CLINICAL INFORMATION OR THE IMPLANTS SHOULD BECOME AVAILABLE, WE RESERVE THE RIGHT TO UPDATE THE INVESTIGATION AND CHANGE THE ROOT CAUSE. OSTEOLYSIS, PERIPROSTHETIC BONE LOSS, DEVICE LOOSENING AND DEVICE FAILURE ARE LISTED IN THE IFU AS ADVERSE EFFECTS.

    Description of Event or Problem · 1

    STAR ANKLE WAS REMOVED AND ANKLE WAS FUSED DUE TO PAIN AND CYST. SURGERY WAS ONE ON (B)(6) 2009. DURING THE CASE, SURGEON OBSERVED LOOSENING ON TIBIAL COMPONENT AND MENISCAL BEARING SURFACE, AND BONE GROWTH IN TALAR COMPONENTS. ALL COMPONENTS WERE REMOVED. NON-STAR ANKLE PAIN, WHICH RESOLVED IN THE SAME YEAR.

    Description of Event or Problem · 1

    STAR ANKLE WAS REMOVED AND ANKLE WAS FUSED DUE TO PAIN AND CYST. SURGERY WAS ONE ON (B)(6) 2009. DURING THE CASE, SURGEON OBSERVED LOOSENING ON TIBIAL COMPONENT AND MENISCAL BEARING SURFACE, AND BONE GROWTH IN TALAR COMPONENTS. ALL COMPONENTS WERE REMOVED. NON-STAR ANKLE PAIN, WHICH RESOLVED IN THE SAME YEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259947 TIBIAL COMP,SINGLECOATED US VERSION, MEDIUM PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME NTG STRYKER GMBH 021219-1972

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention