BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLIDING CORE, UHMPWE,7MM

    MDR report key: 5474904 · Received March 2, 2016

    Report

    Report Number
    0008031020-2016-00096
    Event Type
    Injury
    Date Received
    March 2, 2016
    Date of Event
    July 6, 2015
    Report Date
    February 4, 2016
    Manufacturer
    STRYKER GMBH
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE WAS MANUFACTURED AND DISTRIBUTED BY SMALL BONE INNOVATION, INC., (B)(6) AND IMPLANTED PRIOR TO HOWMEDICA OSTEONICS CORP.¿S PURCHASE OF CERTAIN ASSETS OF SBI ON (B)(6) 2014. STRYKER BECAME LEGAL MANUFACTURER OF THIS PRODUCT ON (B)(6) 2015 AND HAS TAKEN THE RESPONSIBILITY FOR MEDICAL DEVICE REPORTING. DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE IS NOT AVAILABLE TO STRYKER.

    Additional Manufacturer Narrative · 1

    PRODUCT INQUIRY STATED THE TIBIAL COMP, SINGLE COATED US VERSION, SMALL, THE SLIDING CORE, UHMPWE, 7MM AND THE TALAR COMP, SINGLE COATED US VERSION SMALL, RIGHT TO BE THE SUBJECT PRODUCTS. NO FURTHER ASSOCIATED PRODUCTS WERE REPORTED. THE AFFECTED ITEMS WERE DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. THUS, WE EXCLUDED DEVIATIONS IN MATERIAL AND MANUFACTURING. ACCORDING TO INFORMATION RECEIVED AN INTRAOPERATIVE MEDIAL MALLEOLUS FRACTURE HAD OCCURRED WHILE IMPLANTING A STAR ANKLE PROSTHESIS ON (B)(6) 2015, WHICH WAS TREATED BY AN INTERNAL FIXATION. THE REPORTED INFORMATION DID NOT ALLEGE ANY DEFICIENCY IN THE IDENTITY, QUALITY, RELIABILITY, SAFETY, EFFECTIVENESS OR PERFORMANCE OF THE DEVICES. BONE FRACTURE IN GENERAL HAD BEEN EXPERIENCED AND IS NOMINATED IN THE SCIENTIFIC LITERATURE. IT DOES NOT PRESENT AN UNANTICIPATED EVENT IN ITSELF. FRACTURES OF THE MEDIAL OR LATERAL MALLEOLUS MAY OCCUR INTRAOPERATIVELY OR POSTOPERATIVELY. INTRAOPERATIVE FRACTURES MAY BE A RESULT OF POOR BONE QUALITY, INADEQUATE BONE BRIDGE, COMPONENT OVER-SIZING, POOR CUTTING TECHNIQUE, RETRACTOR PLACEMENT, BONY IMPINGEMENT, AND COMPONENT DESIGN. WHEN RECOGNIZED, THESE SHOULD BE FIXED WITH STANDARD TECHNIQUES AND THE PATIENT IMMOBILIZED UNTIL FRACTURE HEALING IS ACHIEVED. RESULTS TYPICALLY ARE NOT COMPROMISED. THE CASE WAS FURTHERMORE REVIEWED BY A CONSULTANT HCP, WHO STATED: ¿THIS IS A SMALL ADDITIONAL SURGICAL STEP WHICH HAS NO IMPACT ON THE CLINICAL OUTCOME¿. HE FURTHERMORE STATED IN A SIMILAR CASE THAT ¿THIS IS A TYPICAL WELL KNOWN COMPLICATION THAT IS RELATED TO THE SURGICAL PROCEDURE AND DEFINITELY NOT UNANTICIPATED. ACCORDING TO OUR DEFINITIONS IT IS CATEGORIZED AS DEVICE RELATED, BUT ONLY RATED AS SEVERITY S2 BECAUSE IT HAS NO IMPACT ON THE POSTOPERATIVE MANAGEMENT AND THE OUTCOME.¿ BASED ON THE ABOVE THE FRACTURE OF THE MEDIAL MALLEOLUS WAS NOT LINKED TO A DEFICIENCY OF THE DEVICES, BUT WAS RATHER RELATED TO THE INTRAOPERATIVE PROCEDURE. 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. BONE FRACTURE IS LISTED IN THE IFU AS A POTENTIAL ADVERSE EFFECT.

    Description of Event or Problem · 1

    INTRAOPERATIVE FRACTURE OF MEDIAL MALLEOLUS DURING THE INDEX SURGERY. IT WAS TREATED BY INTERNAL FIXATION DURING THE SAME SURGERY.

    Description of Event or Problem · 1

    INTRAOPERATIVE FRACTURE OF MEDIAL MALLEOLUS DURING THE INDEX SURGERY. IT WAS TREATED BY INTERNAL FIXATION DURING THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131857 SLIDING CORE, UHMPWE,7MM PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME NTG STRYKER GMBH 1416072

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention