BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN REFLECTION ALL-POLY CUP

    MDR report key: 18557143 · Received January 22, 2024

    Report

    Report Number
    1020279-2024-00198
    Event Type
    Injury
    Date Received
    January 22, 2024
    Date of Event
    June 18, 2009
    Report Date
    June 12, 2024
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    LPH
    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: CASE-2024-00190757-2 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

    CORRECTED DATA: B3 (OCCURRENCE DATE), H6 (INVESTIGATION FINDINGS).

    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" 138 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 ON (B)(6) 2009 DUE TO LOOSENING OF THE CUP AND THE STEM, AND OSTEOLYSIS. 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. ADDITIONALLY PE, CR, CO AND ZN PARTICLES WERE PRESENT IN THE PERIPROSTHETIC TISSUE. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

    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" 138 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 OF THE CUP AND THE STEM, AND OSTEOLYSIS. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1580201 UNKNOWN REFLECTION ALL-POLY CUP PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female Other| R COCR 12/14 FEM HEAD 28 +0| SPEC EF PRI SO 12/14 SZ 2