BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN. POLARCUP SHELL NON-CEMENTED (TI-PLASMA OR TI/HA)

    MDR report key: 14279556 · Received May 4, 2022

    Report

    Report Number
    9613369-2022-00241
    Event Type
    Injury
    Date Received
    May 4, 2022
    Date of Event
    November 21, 2019
    Report Date
    June 12, 2022
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS AG
    Product Code
    JDG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4). CYPRES, A., FIQUET, A., GIRARDIN, P., FITCH, D., BAUCHU, P., BONNARD, O.,& ROY, C. (2019). LONG-TERM OUTCOMES OF A DUAL-MOBILITY CUP AND CEMENTLESS TRIPLE-TAPER FEMORAL STEM COMBINATION IN TOTAL HIP REPLACEMENT: A MULTICENTER RETROSPECTIVE ANALYSIS. JOURNAL OF ORTHOPAEDIC SURGERY AND RESEARCH, 14(1), 1-6. DOI: 10.1186/S13018-019-1436-Y.

    Additional Manufacturer Narrative · 0

    H3, H6: IN THE LITERATURE ARTICLE OF CYPRES ET AL. 2019 [1], IT WAS REPORTED THAT, 14 PATIENTS SUFFERED FROM ASEPTIC LOOSENING AFTER A PRIMARY TOTAL HIP REPLACEMENT SURGERY WITH THE POLAR SYSTEM. THE DEVICES, USED IN TREATMENT, WERE NOT RETURNED FOR INVESTIGATION AND THE PART AND BATCH NUMBER OF THE REPORTED COMPLAINT ARE NOT KNOWN. THEREFORE, IT IS NOT POSSIBLE TO INVESTIGATE WHETHER THE REPORTED DEVICES MET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. THE SEVERITY AND THE FAILURE MODE ARE COVERED THROUGH OUR RISK MANAGEMENT. A THOROUGH MEDICAL INVESTIGATION COULD NOT BE PERFORMED DUE TO INSUFFICIENT INFORMATION. THE REPORTED FAILURE MODE "LOOSENING OF IMPLANT" IS STATED AS A POTENTIAL MEDICAL DEVICE PROBLEM IN THE HIP INSTRUCTION FOR USE OF SMITH AND NEPHEW (LIT. NO. 12.23 ED. 03/21). BASED ON THE PERFORMED INVESTIGATIONS, THE FAILURE MODE AND THE RELATIONSHIP BETWEEN THE DEVICES AND THE REPORTED EVENTS CANNOT BE CONFIRMED. DUE TO INSUFFICIENT INFORMATION, IT IS NOT POSSIBLE TO SPECULATE ABOUT FACTORS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT AND IT IS NOT POSSIBLE TO PERFORM A REVIEW OF PAST CORRECTIVE ACTIONS. NO PROBABLE CAUSE CAN BE DETERMINED AND NO FURTHER ACTIONS WILL BE TAKEN TO THIS DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS COMPLAINT WILL BE REASSESSED. SMITH AND NEPHEW WILL MONITOR THE DEVICES FOR FURTHER SIMILAR ISSUES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON LITERATURE REVIEW "LONG-TERM OUTCOMES OF A DUAL-MOBILITY CUP AND CEMENTLESS TRIPLE-TAPER FEMORAL STEM COMBINATION IN TOTAL HIP REPLACEMENT: A MULTICENTER RETROSPECTIVE ANALYSIS", 14 PATIENTS SUFFERED FROM ASEPTIC LOOSENING AFTER A PRIMARY THR WITH THE POLAR SYSTEM. THE EVENTS WERE RESOLVED BY REVISION SURGERY OF THE CUP. THE OUTCOME OF THE PATIENTS IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1552439 UNKN. POLARCUP SHELL NON-CEMENTED (TI-PLASMA OR TI/HA) PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL JDG SMITH & NEPHEW ORTHOPAEDICS AG UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| H