BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN INTEGRAL BIPOLAR PROSTHESIS

    MDR report key: 18553178 · Received January 22, 2024

    Report

    Report Number
    1020279-2024-00194
    Event Type
    Injury
    Date Received
    January 22, 2024
    Date of Event
    November 9, 2017
    Report Date
    August 19, 2024
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    KWY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE CASE-(B)(4). THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PATIENT COMPLICATION IDENTIFIED THROUGH A REVIEW OF CLINICAL EVIDENCE FROM LITERATURE SOURCES THAT INCLUDES REFERENCE TO THE USE OF A SMITH+NEPHEW PRODUCT. THE REPORTED ISSUE(S) RELATE TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED. SMITH+NEPHEW HAS NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON OUR REVIEW OF ALL CURRENTLY AVAILABLE INFORMATION, WE ARE UNABLE TO CONFIRM A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE OR IDENTIFY A DEFINITIVE ROOT CAUSE. HOWEVER, AS THE USE OF OUR PRODUCT CANNOT BE EXCLUDED AS A POTENTIAL CAUSE OR CONTRIBUTORY FACTOR TO THE REPORTED ISSUE, WE ARE CONSERVATIVELY SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THAT ALTERS THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED. ABE, T., KAKU, N., TABATA, T., TAGOMORI, H., & TSUMURA, H. (2018). CLINICAL RESULTS OF HEMIARTHROPLASTY USING NEW BIPOLAR CUPS FOR STAGE 3 OR LOWER OSTEONECROSIS OF THE FEMORAL HEAD: A RETROSPECTIVE STUDY. MUSCULOSKELETAL SURGERY, 102(3), 241¿246. HTTPS://DOI.ORG/10.1007/S12306-017-0524-6.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: D1 (ALLEGED DEVICE NAME IS AN INTEGRAL BIPOLAR PROSTHESIS).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON LITERATURE REVIEW "CLINICAL RESULTS OF HEMIARTHROPLASTY USING NEW BIPOLAR CUPS FOR STAGE 3 OR LOWER OSTEONECROSIS OF THE FEMORAL HEAD: A RETROSPECTIVE STUDY", 1 PATIENT HAD A ACETABULAR CUP MIGRATION AFTER A HEMIARTHROPLASTY PROCEDURE USING A INTEGRAL BIPOLAR HIP SYSTEM. THE EVENTS WERE RESOLVED BY PERFORMING A REVISION SURGERY IN WHICH THE CUP WAS EXCHANGE TO A COMPETITOR'S DEVICE. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404743 UNKNOWN INTEGRAL BIPOLAR PROSTHESIS PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED KWY SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male Required Intervention| H