BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN. POLARCUP SHELL (UNKN. TYPE)

    MDR report key: 14706886 · Received June 15, 2022

    Report

    Report Number
    9613369-2022-00293
    Event Type
    Injury
    Date Received
    June 15, 2022
    Date of Event
    January 1, 2006
    Report Date
    August 4, 2022
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS AG
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: CASE (B)(4). FIQUET, A., & NOYER, D. (2006). ¿POLARSYSTEM¿ DUAL MOBILITY HIP PROSTHESIS AND ¿MINIMALLY INVASIVE SURGERY¿(MIS). INTERACTIVE SURGERY, 1(1), 51-55. DOI: 10.1007/S11610-006-0004-4.

    Additional Manufacturer Narrative · 0

    THE STUDY OF A. FIQUET A. ET. AL. [1] REPORTS ¿¿POLARSYSTEM¿¿ DUAL MOBILITY HIP PROSTHESIS AND ¿¿MINIMALLY INVASIVE SURGERY¿¿ (MIS)". IT WAS REPORTED THAT ONE (1) PATIENT WHO INITIALLY UNDERWENT PRIMARY IMPLANTATION OF A DUAL MOBILITY HIP PROSTHESIS COMPRISING OF A POLARCUP AND A POLARSTEM TO TREAT EITHER AN OSTEOARTHRITIS DIAGNOSIS OR A NECK FRACTURE, EXPERIENCED A POSTOPERATIVE STREPTOCOCCUS B INFECTION THAT OCCURRED THREE AND A HALF (3.5) MONTHS POSTOPERATIVELY. A PROSTHESIS CLEANING AND A PROLONGED ANTIBIOTHERAPY WAS CONDUCTED AND ADMINISTERED. THE PATIENT'S OUTCOME IS UNKNOWN. AS THIS IS A LITERATURE COMPLAINT, THE DEVICES USED IN TREATMENT, WERE NOT RETURNED FOR INVESTIGATION. THE PART AND THE BATCH NUMBER ARE NOT KNOWN. THEREFORE, IT IS NOT POSSIBLE TO INVESTIGATE WHETHER THE REPORTED DEVICE MET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. AS NO DEVICE WAS RECEIVED FOR INVESTIGATION, A VISUAL INSPECTION COULD NOT BE PERFORMED. A COMPLAINT HISTORY REVIEW WAS PERFORMED. THE OCCURRENCE OF THE REPORTED FAILURE MODE IS WITHIN ITS EXPECTED RISK LEVEL AS PER RISK MANAGEMENT. REVIEW OF PAST CORRECTIVE ACTIONS WAS PERFORMED. NO FURTHER ESCALATION IS REQUIRED. A REVIEW OF THE RISK MANAGEMENT DOCUMENTATION VERIFIES THE FAILURE MODE AND SEVERITY OF THE REPORTED ISSUE. THE INSTRUCTIONS FOR USE LISTS SEVERAL POSSIBLE ADVERSE EFFECTS RESULTING FROM A HIP ARTHROPLASTY. A MEDICAL INVESTIGATION WAS CONDUCTED. THE DATA PRESENTED IN THE AGED ARTICLE DOES NOT PROVIDE INSIGHT OR RELEVANCE TO CURRENT CLINICAL OUTCOMES FOR THE PRODUCT/DEVICE. WITHOUT CLINICALLY RELEVANT PATIENT-SPECIFIC SUPPORTING DOCUMENTATION, A THOROUGH MEDICAL INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE CONDUCTED INVESTIGATION THE FAILURE MODE AND THE RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED EVENT CANNOT BE CONFIRMED. DUE TO INSUFFICIENT INFORMATION IT IS NOT POSSIBLE TO SPECULATE ABOUT FACTORS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. NO PROBABLE CAUSE CAN BE DETERMINED. TO DATE, NO FURTHER ACTIONS WILL BE TAKEN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS COMPLAINT WILL BE REASSESSED. SMITH AND NEPHEW WILL MONITOR THE DEVICES FOR FURTHER SIMILAR ISSUES. INTERNAL COMPLAINT REFERENCE NUMBER: (B)(4). [1] FIQUET, A., NOYER, D. ¿POLARSYSTEM¿ DUAL MOBILITY HIP PROSTHESIS AND ¿MINIMALLY INVASIVE SURGERY¿ (MIS). INTERACT SURG 1, 51¿55 (2006). HTTPS://DOI.ORG/10.1007/S11610-006-0004-4.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, ON LITERATURE REVIEW ""¿¿POLARSYSTEM¿¿ DUAL MOBILITY HIP PROSTHESIS AND ¿¿MINIMALLY INVASIVE SURGERY¿¿ (MIS)"", ONE (1) PATIENT WHO INITIALLY UNDERWENT PRIMARY IMPLANTATION OF A DUAL MOBILITY HIP PROSTHESIS COMPRISING OF A POLARCUP AND A POLARSTEM TO TREAT EITHER AN OSTEOARTHRITIS DIAGNOSIS OR A NECK FRACTURE, EXPERIENCED A POSTOPERATIVE STREPTOCOCCUS B INFECTION THAT OCCURRED THREE AND A HALF (3.5) MONTHS POSTOPERATIVELY. A PROSTHESIS CLEANING AND A PROLONGED ANTIBIOTHERAPY WAS CONDUCTED AND ADMINISTERED. THE PATIENT'S OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2209645 UNKN. POLARCUP SHELL (UNKN. TYPE) PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS LZO SMITH & NEPHEW ORTHOPAEDICS AG UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other UNKN. POLARSTEM (UNKN. TYPE)