BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRON EF PRIMARY HIGH OFFSET 12/14 FEM SZ 1

    MDR report key: 18557149 · Received January 22, 2024

    Report

    Report Number
    1020279-2024-00199
    Event Type
    Injury
    Date Received
    January 22, 2024
    Date of Event
    May 19, 2011
    Report Date
    April 24, 2024
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDI
    UDI-DI
    03596010195562
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE: (B)(4). ARTICLE: WOLF, S., JOHANNESSEN, A. C., ELLISON, P., FURNES, O., HALLAN, G., ROGG, K., ... & HL, P. J. (2022). INFLAMMATORY TISSUE REACTIONS AROUND ASEPTICALLY LOOSE CEMENTED HIP PROSTHESES: A RETRIEVAL STUDY OF THE SPECTRON EF STEM WITH REFLECTION ALL-POLY ACETABULAR CUP. JOURNAL OF BIOMEDICAL MATERIALS RESEARCH PART B: APPLIED BIOMATERIALS, 110(7), 1624-1636. HTTPS://DOI.ORG/10.1002/JBM.B.35023. H3, H6: 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.

    Additional Manufacturer Narrative · 0

    H10: ADDITIONAL INFORMATION RECEIVED BY THE MANUFACTURER HAS IDENTIFIED THAT THIS EVENT SHOULD BE RE-EVALUATED FOR MDR REPORTING. A RESPONSE WAS RECEIVED FROM THE PUBLICATION AUTHOR, INDICATING THAT THE POLYETHYLENE (PE) PARTICLES LIBERATED BY THE CUP'S WEAR MAY HAVE BEEN THE PRIMARY CAUSE OF THE OSTEOLYSIS IN THE FEMUR, AS WELL AS THE LOOSENING OF THE STEM. THEREFORE, THE STEM WILL BE HANDLED AS A CONCOMITANT DEVICE UNDER REPORT NUMBER 1020279-2024-00200.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON LITERATURE REVIEW "INFLAMMATORY TISSUE REACTIONS AROUND ASEPTICALLY LOOSE CEMENTED HIP PROSTHESES: A RETRIEVAL STUDY OF THE SPECTRON EF STEM WITH REFLECTION ALL-POLY ACETABULAR CUP" 93 MONTHS AFTER A THA SURGERY, WHERE AN SPECTRON EF STEM AND A REFLECTION NON-CROSSLINKED ALL-POLLY CUP WERE IMPLANTED, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO LOOSENING AND OSTEOLYSIS OF THE CUP, AS WELL AS LOOSENING OF THE STEM. THE STUDY DETERMINED THAT BOTH THE STEM AND THE CUP WERE WORN, ADDITIONALLY PE, CR, CO AND ZN PARTICLES WERE PRESENT IN THE PERIPROSTHETIC TISSUE. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON LITERATURE REVIEW "INFLAMMATORY TISSUE REACTIONS AROUND ASEPTICALLY LOOSE CEMENTED HIP PROSTHESES: A RETRIEVAL STUDY OF THE SPECTRON EF STEM WITH REFLECTION ALL-POLY ACETABULAR CUP" 93 MONTHS AFTER A THA SURGERY PERFORMED ON (B)(6) 2003, DUE TO IDIOPATHIC COXARTHROSIS, WHERE A COCR 12/14 FEM HEAD 28 +0, AN SPEC EF PRIM HO 12/14 SZ 1 AND A REFLECTION NON-CROSSLINKED ALL-POLLY CUP WERE IMPLANTED, THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2011, DUE TO LOOSENING AND OSTEOLYSIS OF THE CUP, AS WELL AS LOOSENING OF THE STEM. THE STUDY DETERMINED THAT THE CUP WAS WORN, ADDITIONALLY PE, CR, CO AND ZN PARTICLES WERE PRESENT IN THE PERIPROSTHETIC TISSUE. THE POLYETHYLENE WEAR FROM THE REFLECTION CUP WAS AN IMPORTANT FACTOR LEADING TO OSTEOLYSIS AND LOOSENING OF THE CUP AND STEM. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1602645 SPECTRON EF PRIMARY HIGH OFFSET 12/14 FEM SZ 1 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI SMITH & NEPHEW, INC. 04AT77847 03596010195562

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Other| R