BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN. SL-PLUS STEM

    MDR report key: 13480004 · Received February 8, 2022

    Report

    Report Number
    9613369-2022-00021
    Event Type
    Injury
    Date Received
    February 8, 2022
    Date of Event
    June 13, 2009
    Report Date
    April 6, 2022
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS AG
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4). BERGSCHMIDT, P., BADER, R., FINZE, S., GANKOVYCH, A., KUNDT, G., & MITTELMEIER, W. (2010). CEMENTLESS TOTAL HIP REPLACEMENT: A PROSPECTIVE CLINICAL STUDY OF THE EARLY FUNCTIONAL AND RADIOLOGICAL OUTCOMES OF THREE DIFFERENT HIP STEMS. ARCHIVES OF ORTHOPAEDIC AND TRAUMA SURGERY, 130(1), 125-133. 10.1007/S00402-009-0907-8.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, ON LITERATURE REVIEW ""CEMENTLESS TOTAL HIP REPLACEMENT: A (B)(6) STUDY OF THE EARLY FUNCTIONAL AND RADIOLOGICAL OUTCOMES OF THREE DIFFERENT HIP STEMS"", A (B)(6) YEAR OLD MALE PATIENT WHO HAD INITIALLY A SL-PLUS STEM IMPLANTED EXPERIENCED RADIOLUCENT LINES UP TO 3 MM IN THE PROXIMAL PART OF THE FEMUR DUE TO STRESS SHIELDING AT 12 MONTHS POSTOPERATIVELY. IN ADDITION, A GREATER TROCHANTER APEX FRACTURE COULD BE DETECTED AT THE SECOND POSTOPERATIVE EVALUATION. NO PROGRESSION OF THE RADIOLUCENT LINES WAS SEEN 12 MONTHS POSTOPERATIVELY AND THE STEM DELIVERED SATISFACTORY CLINICAL RESULTS AS REPORTED BY THE AUTHORS. FURTHER INFORMATION ON THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1550789 UNKN. SL-PLUS STEM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH SMITH & NEPHEW ORTHOPAEDICS AG UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Other