BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN PERI-LOC AND PERI-LOC VLP IMPL

    MDR report key: 20107015 · Received August 30, 2024

    Report

    Report Number
    1020279-2024-01718
    Event Type
    Injury
    Date Received
    August 30, 2024
    Report Date
    August 30, 2024
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE: (B)(4). FRENCH JMR, FILER J, HOGAN K, ET AL. COMPUTER HEXAPOD-ASSISTED ORTHOPAEDIC SURGERY FOR THE CORRECTION OF MULTIPLANAR DEFORMITIES THROUGHOUT THE LOWER LIMB. STRATEGIES TRAUMA LIMB RECONSTR 2024;19(1):9¿14.DOI: 10.5005/JP-JOURNALS-10080-1608. SECTION 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON LITERATURE REVIEW " COMPUTER HEXAPOD-ASSISTED ORTHOPAEDIC SURGERY FOR THE CORRECTION OF MULTIPLANAR DEFORMITIES THROUGHOUT THE LOWER LIMB ", ONE PATIENT WHO UNDERWENT A MULTIPLANAR DISTAL TIBIAL CORRECTION FOR TRAUMATIC MALUNION SUFFERED A BROKEN PLATE POSTOPERATIVELY AFTER A COMPUTERISED HEXAPOD-ASSISTED ORTHOPAEDIC SURGERY (CHAOS) PROCEDURE USING A PERI-LOCK FROM SMITH AND NEPHEW. THE PATIENT UNDERWENT REVISION SURGERY TO TREAT THIS EVENT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1990234 UNKN PERI-LOC AND PERI-LOC VLP IMPL PLATE, FIXATION, BONE HRS SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H