BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLIDING CORE, UHMPWE,6M (STERILE PACKAGED)

    MDR report key: 5368122 · Received January 14, 2016

    Report

    Report Number
    0008031020-2016-00011
    Event Type
    Injury
    Date Received
    January 14, 2016
    Date of Event
    December 18, 2015
    Report Date
    December 19, 2015
    Manufacturer
    STRYKER GMBH
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REFERRING TO THE PRODUCT INQUIRY ALL REPORTED ITEMS ARE CONSIDERED PRIMARY PRODUCTS. THE EXPLANTED DEVICES WERE NOT AVAILABLE TO (B)(4). HOWEVER, NO PRODUCT MALFUNCTION WAS REPORTED; THE REPORTED IMPLANTS WERE ¿TAKEN OUT DUE TO INFECTION¿ ACCORDING TO THE EVENT DESCRIPTION. REVIEW OF THE DEVICE HISTORY RECORDS OF ALL PRODUCTS REPORTED REVEALED NO CONSPICUITIES. THE ITEMS WERE DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. SINCE THE MANUFACTURING DOCUMENTS (INCLUDING THE PACKAGING AND STERILIZATION DOCUMENTATION) SHOWED NO DEVIATION AND BASED ON THE MEDICAL EXPERIENCES CITED (SEE ¿MEDICAL BACKGROUND / INFORMATION¿) THE EVENT WAS NOT LINKED TO A DEFICIENCY OF THE DEVICES. HOWEVER, ON THE BASIS OF THE LIMITED INFORMATION GIVEN THE EXACT ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. A REVIEW OF THE EVENT IN LINE WITH ¿DQI 13-001 HANDLING OF INFECTION COMPLAINTS¿ INCLUDING ¿DQF 13-002 INFECTION COMPLAINTS - CHECKLIST INVESTIGATOR¿ WAS DEEMED NOT NECESSARY SINCE NO FURTHER INFORMATION REGARDING THE KIND OF INFECTION, PATIENT OUTCOME ETC. WAS PROVIDED ALTHOUGH REPEATEDLY REQUESTED. THIS ALSO APPLIES TO THE QUESTIONNAIRE ¿DQF 13-003 INFECTION COMPLAINTS - CHECKLIST CUSTOMER¿, WHICH WAS SENT OUT AS USUAL IN INFECTION CASES; THE FORM WAS NOT RETURNED. NO NON-CONFORMITY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE WAS MANUFACTURED AND DISTRIBUTED BY (B)(4) . DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    A TOTAL ANKLE WAS TAKEN OUT DUE TO INFECTION. ORIGINAL SURGERY DATE WAS (B)(6) 2015. AN ANTIBIOTIC CEMENT SPACER WAS USED AFTER THEY WERE REMOVED. ON 28-DEC-2015, SALES REP REPORTED THAT NON UNION WAS NOT REPORTED.

    Description of Event or Problem · 1

    A TOTAL ANKLE WAS TAKEN OUT DUE TO INFECTION. ORIGINAL SURGERY DATE WAS (B)(6) 2015. AN ANTIBIOTIC CEMENT SPACER WAS USED AFTER THEY WERE REMOVED. ON (B)(6) 2015, SALES REP REPORTED THAT NON UNION WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25086 SLIDING CORE, UHMPWE,6M (STERILE PACKAGED) PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME NTG STRYKER GMBH 1426015

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention