BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 14279770 · Received May 4, 2022

    Report

    Report Number
    9613369-2022-00251
    Event Type
    Injury
    Date Received
    May 4, 2022
    Date of Event
    November 21, 2019
    Report Date
    July 19, 2022
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS AG
    Product Code
    KWY
    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: DOI.ORG/10.1186/S13018-019-1436-Y.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION H6: B22 CODE ADDED. INTERNAL COMPLAINT REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    H3, H6: IN THE LITERATURE ARTICLE OF CYPRES ET AL. 2019 [1], IT WAS REPORTED THAT, 1 PATIENT SUFFERED FROM BONE ATROPHY AFTER A PRIMARY TOTAL HIP REPLACEMENT SURGERY WITH THE POLAR SYSTEM. THE DEVICE, USED IN TREATMENT, WAS 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 DEVICE 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. A REVIEW OF THE DEVICE LABELLING REVEALED THAT THE IFU (LIT. NO. 12.23 ED. 03/21) STATES KNOWN POSSIBLE RISK FACTORS AND SIDE EFFECTS IN COMBINATION WITH THE IMPLANTATION OF A HIP PROSTHESIS. BASED ON THE PERFORMED INVESTIGATIONS, 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 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 "EXCELLENT MIDTERM SURVIVAL AND FUNCTIONAL OUTCOMES OF A FULLY HYDROXYAPATITE-COATED CEMENTLESS STEM: FIRST RESULTS OF A PROSPECTIVE MULTICENTER STUDY", 1 PATIENT UNDERWENT A REVISION SURGERY WHERE THE STEM WAS REVISED 6 WEEKS AFTER INITIAL SURGERY DUE TO UNKNOWN REASONS. NO FURTHER INFORMATION IS AVAILABLE. THERE IS NO INFORMATION WITHIN THE STUDY TO DETERMINE WHETHER THESE ADVERSE EVENTS OCCURRED IN (B)(6) OR IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1459870 UNKNOWN POLARCUP SHELL NON-CEMENTED (TI-PLASMA OR TI/HA) PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED KWY SMITH & NEPHEW ORTHOPAEDICS AG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other