BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SL-PLUS STEM LATERAL 1 NON-CEMENTED

    MDR report key: 10059237 · Received May 14, 2020

    Report

    Report Number
    9613369-2020-00083
    Event Type
    Malfunction
    Date Received
    May 14, 2020
    Date of Event
    April 17, 2020
    Report Date
    September 22, 2020
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS AG
    Product Code
    LZO
    PMA / PMN Number
    K072852
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A REVISION SURGERY WAS BEING PERFORMED DUE TO FRACTURE AND PAIN. THE CLAIMED ARTICLE WAS AN UNKNOWN SL-PLUS STEM, WHICH INTENT USE IS IN TREATMENT. THE DEVICE WASN'T REVISED, THE FRACTURE WAS HEALED USING CABLES. CLINICAL/MEDICAL DOCUMENTATION WASN'T PROVIDED, IT IS NOT CLEAR IN WHICH AREA OF THE HIP THE FRACTURE OCCURED. FURTHERMORE NO BATCH NUMBER WAS COMMUNICATED. A THOROUGH BATCH RELATED DEVICE HISTORY AND COMPLAINT HISTORY REVIEW COULDN'T BE PERFORMED. AT THAT TIME OF INVESTIGATION, IT WILL BE ASSUMED THAT THE FRACTURE OCCURRED DUE TO THE PATIENTS FALL LIKE COMMUNICATED. NEVERTHELESS, S+N WILL MONITOR THIS DEVICE FOR SIMILAR ISSUES. SHOULD ADDITIONAL INFORMATION GET AVAILABLE, THE ISSUE CAN BE RE-ASSESSED

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS BEING PERFORMED DUE TO FRACTURE AND PAIN THE CAUSE WAS PATIENT'S FALLING. IT'S UNKNOWN IF THERE WAS A DELAY. INJURY TO THE PATIENT REPORTED. THE DEVICES WERE NOT REMOVED BUT CABLE HAS BEEN IMPLANTED TO RESOLVE THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523373 SL-PLUS STEM LATERAL 1 NON-CEMENTED PRSTHSS,HIP,SEMI-CNSTRND,METAL/CERAMIC/PLYMR,CMNTD OR NON-POROUS,UNCMNTD LZO SMITH & NEPHEW ORTHOPAEDICS AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R