BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN REDAPT HIP ACETABULAR IMPLANT

    MDR report key: 17770363 · Received September 18, 2023

    Report

    Report Number
    9613369-2023-00187
    Event Type
    Injury
    Date Received
    September 18, 2023
    Date of Event
    April 13, 2023
    Report Date
    October 11, 2023
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INADVERTENTLY SUBMITTED UNDER MANUFACTURER REPORT NUMBER "961336", CORRECT MANUFACTURER REPORT NUMBER IS "1020279."

    Additional Manufacturer Narrative · 0

    H10: 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. MUTHUSAMY, N., SHICHMAN, I., SICAT, C. S., MARWIN, S., MEFTAH, M., & SCHWARZKOPF, R. (2022). MIDTERM OUTCOMES OF A MONOBLOCK DUAL-MOBILITY CUP CEMENTED INTO A FULLY POROUS ACETABULAR COMPONENT IN REVISION TOTAL HIP ARTHROPLASTY. THE JOURNAL OF HIP SURGERY, 6(03), 117-123. DOI: DOI: 10.1055/S-0042-1756277.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON LITERATURE REVIEW "MIDTERM OUTCOMES OF A MONOBLOCK DUAL-MOBILITY CUP CEMENTED INTO A FULLY POROUS ACETABULAR COMPONENT IN REVISION TOTAL HIP ARTHROPLASTY", 1 PATIENT SUFFERED AN ASEPTIC LOOSENING DUE TO SEVERE OSTEOLYSIS OF THE ACETABULAR CUP 1.64 YEARS AFTER A REVISION TOTAL HIP ARTHROPLASTY PROCEDURE USING A POLARCUP DUAL-MOBILITY CONSTRUCT AND A REDAPT ACETABULAR SHELL. THE EVENT WAS TREATED WITH AN ACETABULAR REVISION WHERE BOTH IMPLANTS WERE REMOVED AND A CUSTOM TRIFLANGED CONSTRUCT WAS IMPLANTED. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2145473 UNKNOWN REDAPT HIP ACETABULAR IMPLANT PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention