BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_SELZACH_PRODUCT

    MDR report key: 5079259 · Received September 15, 2015

    Report

    Report Number
    0008031020-2015-00382
    Event Type
    Injury
    Date Received
    September 15, 2015
    Date of Event
    August 24, 2015
    Report Date
    August 24, 2015
    Manufacturer
    STRYKER GMBH
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UNKNOWN STAR ANKLE POLY. RETAINED BY SURGEON.

    Additional Manufacturer Narrative · 1

    REFERRING TO THE PRODUCT INQUIRY THE ¿UNKNOWN_SELZACH_PRODUCT (UNKNOWN, STAR ANKLE)¿ IS CONSIDERED THE PRIMARY PRODUCT. NO FURTHER ASSOCIATED PRODUCT WAS REPORTED. ON REQUEST THE CUSTOMER REFUSED TO COMPLETE THE QUESTIONNAIRE ¿DQF 13-003 INFECTION COMPLAINTS - CHECKLIST CUSTOMER¿ WHICH WAS SENT OUT AS USUAL IN INFECTION CASES. HE ALSO REFUSED TO PROVIDE ANY FURTHER INFORMATION. THUS, A REVIEW OF THE EVENT IN LINE WITH ¿DQI 13-001 HANDLING OF INFECTION COMPLAINTS¿ INCLUDING ¿DQF 13-002 INFECTION COMPLAINTS - CHECKLIST INVESTIGATION¿ WAS DEEMED NOT APPROPRIATE. THE POTENTIAL RISK OF INFECTION CAUSED BY STERILE (GAMMA STERILIZATION OR EO STERILIZATION) PACKED STRYKER IMPLANTS AND INSTRUMENTS HAS BEEN EVALUATED IN GENERAL BY A CONSULTANT HCP; HIS ¿CLINICAL OPINION¿ IN EXCERPTS: ¿OBJECTIVE: IT SHALL BE ESTIMATED IN GENERAL FROM A CLINICAL POINT OF VIEW, WHETHER STRYKER DEVICES, WHICH HAVE BEEN DELIVERED IN STERILE PACKED CONDITION (GAMMA STERILIZATION OR EO STERILIZATION), BEAR A POTENTIAL RISK TO CAUSING A BACTERIAL CONTAMINATION THAT MAY RESULT IN A MANIFEST INFECTION. POTENTIAL ROOT CAUSES FOR CONTAMINATION AND INFECTION. ANY KIND OF SURGERY BEARS THE RISK OF INFECTION. IN TRAUMA AND ORTHOPEDIC SURGERY WITH EXTERNAL OR INTERNAL FIXATION IMPLANTS OR ENDOPROSTHESES THE INFECTION RISK VARIES BETWEEN 0.5 % AND 5 %, EXCEPTIONALLY UP TO 10 % AND BEYOND, MAINLY DEPENDING ON THE RESPECTIVE SURGICAL PROCEDURE AND THE TYPICAL PATIENT POPULATION. IN SOME PROCEDURES INFECTION RATES UP TO 100 % (I.E. PIN TRACK INFECTION IN EXTERNAL FIXATION) ARE DESCRIBED IN THE SCIENTIFIC LITERATURE. BASED ON THESE ESTIMATIONS THE FOLLOWING ESTIMATION IS GIVEN: IN THE CASE OF A REPORTED INFECTION IN A PATIENT, WHO HAS RECEIVED A STERILE PACKED STRYKER IMPLANT, OR WHEN DURING SURGERY A STERILE PACKAGED STRYKER INSTRUMENT HAS BEEN USED, THE PROBABILITY THAT THIS INFECTION IS CAUSED IN THE SPHERE OF STRYKER¿S INFLUENCE IS ESTIMATED LESS THAN 0.001 % (10 PPM). BY IMPLICATION, THE PROBABILITY THAT SUCH AN INFECTION IS CAUSED IN THE SPHERE OF THE HOSPITAL OR CAUSED BY ANY OTHER FATEFUL EVENT IS ESTIMATED GREATER THAN 99.999 %. RECOMMENDED MEASURES IN THE CASE OF AN COMPLAINT CONCERNING AN INFECTION IN RELATIONSHIP TO A STERILE PACKAGED STRYKER DEVICE. ALTHOUGH THERE IS A NEGLIGIBLE PROBABILITY THAT AN INFECTION HAS BEEN CAUSED BY A STERILE PACKED DEVICE BY AN EVENT IN THE FIELD OF RESPONSIBILITY OF STRYKER, THE FOLLOWING MEASURES ARE RECOMMENDED IN THE CASE OF A RESPECTIVE COMPLAINT DUE TO FORMAL REASONS: REVIEW OF THE PACKAGING PROCESS (PRIOR TO STERILIZATION) DOCUMENTS. REVIEW OF THE STERILIZATION DOCUMENTS. REVIEW OF THE STORAGE AND DELIVERY DOCUMENTS. IF NONE OF THE NOMINATED DOCUMENTS OFFERS A DEVIATION, THE AFFECTED STERILE PACKED STRYKER DEVICE CAN BE EXCLUDED AS ROOT CAUSE OF THE REPORTED INFECTION WITH ALMOST ABSOLUTE CERTAINTY AND NO FURTHER ACTION IS REQUIRED FROM A CLINICAL POINT OF VIEW [...]¿ IN THIS CASE REVIEW OF THE PACKAGING, STERILIZATION AND STORAGE/DELIVERY DOCUMENTS WAS NOT POSSIBLE SINCE THE LOT CODE OF THE REPORTED PRODUCT IS NOT AVAILABLE. GENERAL TECHNICAL ASPECTS: IF THE STERILE BARRIER OF THE PACKAGE IS OPENED OR SUSPECTED BEING IMPAIRED (I.E. TRANSPORT ISSUE OR INSUFFICIENT USAGE IN HOSPITAL) THE IFU INSTRUCT THAT IN THESE CASES THE PRODUCT MUST BE RE STERILIZED IN CASE OF USE. STERILIZED STRYKER IMPLANTS ARE GRANTED TO BE STERILE FOR FIVE YEARS (AS VISIBLE ON THE LABELS) IF THE PACKAGING IS UNDAMAGED. BASED ON THE ABOVE OBSERVATIONS AND ON THE LIMITED INFORMATION GIVEN THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. REFERRING TO THE ABOVE NO NONCONFORMITY WAS IDENTIFIED.

    Description of Event or Problem · 1

    I WAS NOTIFIED BY THE SURGEON THAT THEY WERE DOING A STAR REMOVAL AT (B)(6) HOSPITAL. THE ONLY DETAILS REGARDING THE CASE I WAS GIVEN WERE THAT THE PATIENT WAS INFECTED AND REMOVAL OF THE STAR IMPLANT WAS NEEDED. HE WAS PLANNING TO IMPLANT AN ANTIBIOTIC SPACER AND THEN COME BACK AND DO A REVISION SURGERY LATER. THE SURGEON WILL RETAIN THE DEVICES.

    Description of Event or Problem · 1

    I WAS NOTIFIED BY THE SURGEON THAT THEY WERE DOING A STAR REMOVAL AT (B)(6) HOSPITAL THE ONLY DETAILS REGARDING THE CASE I WAS GIVEN WERE THAT THE PATIENT WAS INFECTED AND REMOVAL OF THE STAR IMPLANT WAS NEEDED. HE WAS PLANNING TO IMPLANT AN ANTIBIOTIC SPACER AND THEN COME BACK AND DO A REVISION SURGERY LATER. THE SURGEON WILL RETAIN THE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610435 UNKNOWN_SELZACH_PRODUCT PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME NTG STRYKER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention