BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK STAR MOBILE BEARING COMPONENT

    MDR report key: 7153309 · Received December 28, 2017

    Report

    Report Number
    0008031020-2017-00725
    Event Type
    Injury
    Date Received
    December 28, 2017
    Date of Event
    October 25, 2017
    Report Date
    January 12, 2018
    Manufacturer
    STRYKER GMBH
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION REVEALED ALL THREE REPORTED STAR IMPLANTS TO BE PRIMARY PRODUCTS. NO FURTHER ASSOCIATED PRODUCTS WERE REPORTED. THE REPORTED PRODUCTS WERE NOT AVAILABLE TO STRYKER KIEL (¿CLINICAL STUDY¿). THE PRODUCT DATA (CATALOGUE NUMBERS AND LOT CODES) WERE NOT PROVIDED. THUS, NEITHER A PHYSICAL EXAMINATION NOR A PRODUCT HISTORY REVIEW WAS POSSIBLE IN THIS CASE. HOWEVER, THE REPORTED ISSUE WAS CLASSIFIED BEING NOT DEVICE RELATED BY A CONSULTING HEALTH CARE PROFESSIONAL. THE EVENT WAS FILED DURING THE ¿2-YEAR POST-APPROVAL STUDY TO INVESTIGATE THE STAR ANKLE UNDER ACTUAL CONDITIONS OF USE¿ (C09_AE_002) AND HAS BEEN CLASSIFIED AS AN ADVERSE EVENT (AE) ¿ RELATIONSHIP TO THE IMPLANT: UNRELATED. IT WAS REPORTED: "SUBJECT [(B)(6)-YEAR-OLD MALE PATIENT] EXPERIENCED WOUND DEHISCENCE ON (B)(6) 2017 FOLLOWING RECEIPT OF STAR ANKLE ON RIGHT ANKLE ON (B)(6) 2017. WOUND WASHED AND SUBJECT TREATED WITH ANTIBIOTICS. SUBJECT PLACED IN CAM BOOT. EVENT RESOLVED ON (B)(6) 2017." THE REPORTED ISSUE WAS EVALUATED BY A HEALTH CARE PROFESSIONAL TO DEFINE WHETHER THE PRODUCTS DID CONTRIBUTE TO THE EVENT. THE HCP DEFINED THE CASE AS AE, ACCORDING TO PROCEDURE DQI 20-030 ¿CLINICAL INVESTIGATION - ADVERSE EVENT REPORTING¿ A AE (ADVERSE EVENT) IS NON-DEVICE RELATED. THEREFORE, A RELATIONSHIP BETWEEN THE IMPLANTS AND THE REPORTED EVENT CAN BE EXCLUDED. REFERRING TO THE ABOVE A REVIEW OF THE EVENT IN LINE WITH ¿DQF 13-002 INFECTION COMPLAINTS CHECKLIST INVESTIGATOR¿ WAS NOT EXPEDIENT. LIKEWISE, THE COMPLETED ¿DQF 13-003 INFECTION COMPLAINTS CHECKLIST CUSTOMER¿ WAS DEEMED NOT NECESSARY IN THIS CASE. REVIEW OF THE COMPLAINT HISTORY, RISK ANALYSIS AND CAPA DATABASES WAS DEEMED DISPENSABLE SINCE THE PRODUCTS WERE NOT SUSPECTED TO HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE ABOVE OBSERVATIONS THE EVENT IS NOT LINKED TO A DEFICIENCY OF A DEVICE BUT IS RATHER CONSIDERED PATIENT RELATED. NO NON-CONFORMITY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    AS REPORTED: "SUBJECT EXPERIENCED WOUND DEHISCENCE ON (B)(6) 2017 FOLLOWING RECEIPT OF STAR ANKLE ON RIGHT ANKLE ON (B)(6) 2017. WOUND WASHED AND SUBJECT TREATED WITH ANTIBIOTICS. SUBJECT PLACED IN CAM BOOT. EVENT RESOLVED ON (B)(6) 2017." SUBMITTED AER FORM INDICATES THAT X-RAYS/DICOMS/CT-SCANS ARE NOT AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED: "SUBJECT EXPERIENCED WOUND DEHISCENCE ON (B)(6) 2017 FOLLOWING RECEIPT OF STAR ANKLE ON RIGHT ANKLE ON (B)(6) 2017. WOUND WASHED AND SUBJECT TREATED WITH ANTIBIOTICS. SUBJECT PLACED IN CAM BOOT. EVENT RESOLVED ON (B)(6) 2017." SUBMITTED AER FORM INDICATES THAT X-RAYS/DICOMS/CT-SCANS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929840 UNK STAR MOBILE BEARING COMPONENT PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME NTG STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention