BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN. SL-PLUS STEM

    MDR report key: 13480082 · Received February 8, 2022

    Report

    Report Number
    9613369-2022-00022
    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

    RESULTS OF INVESTIGATION: THE STUDY OF BERGSCHMIDT P. ET AL [1] REPORTS 22 PATIENTS WHO WERE TREATED USING SMITH AND NEPHEW SL-PLUS STEM PROTHESIS. ONE ASYMPTOMATIC PATIENT WHO HAD INITIALLY A SL-PLUS STEM IMPLANTED REVEALED A GREATER TROCHANTER APEX FRACTURE THAT COULD BE DETECTED AT THE SECOND POSTOPERATIVE EVALUATION (UNSPECIFIED TIME FRAME). NO REVISION SURGERY WAS REQUIRED DURING MEDICAL FOLLOW UPS WITHIN THE 12 POSTOPERATIVE MONTHS TIME FRAME. FURTHER INFORMATION ON THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. THE COMPLAINT DEVICE, USED IN TREATMENT, WAS NOT RECEIVED FOR INVESTIGATION, A VISUAL INSPECTION COULD NOT BE PERFORMED. THE PART AND THE BATCH NUMBER OF THE DEVICE IS NOT KNOWN. THEREFORE, THE BATCH RECORD REVIEW COULD NOT BE PERFORMED. THE COMPLAINT HISTORY REVIEW WAS PERFORMED, AND A REVIEW OF THE RISK MANAGEMENT DOCUMENTATION VERIFIES THE FAILURE MODE AND SEVERITY OF THE REPORTED ISSUE. THE DEVICE LABELING WAS REVIEWED, THE IFU FOR THE COMPLAINT DEVICE STATED HIP FRACTURE AMONG POSSIBLE SIDE EFFECTS RESULTING FROM KNEE ARTHROPLASTY. A REVIEW OF PAST CORRECTIVE ACTIONS WAS PERFORMED. NO FURTHER ESCALATION IS REQUIRED. A THOROUGH MEDICAL INVESTIGATION COULD NOT BE PERFORMED AS THE CLINICALLY RELEVANT PATIENT-SPECIFIC SUPPORTING DOCUMENTATION WAS NOT PROVIDED. BASED ON OUR INVESTIGATIONS THE FAILURE MODE CANNOT BE CONFIRMED AND THE ROOT CAUSE OF THE PROBLEM STAYS UNDETERMINED DUE TO INSUFFICIENT INFORMATION. TO DATE, NO FURTHER ACTIONS WILL BE TAKEN. SMITH AND NEPHEW WILL MONITOR THE DEVICES FOR FURTHER SIMILAR ISSUES. [1]: BERGSCHMIDT P, BADER R, FINZE S, GANKOVYCH A, KUNDT G, MITTELMEIER W. CEMENTLESS TOTAL HIP REPLACEMENT: A PROSPECTIVE CLINICAL STUDY OF THE EARLY FUNCTIONAL AND RADIOLOGICAL OUTCOMES OF THREE DIFFERENT HIP STEMS. ARCH ORTHOP TRAUMA SURG. 2010 JAN;130(1):125-33. DOI: 10.1007/S00402-009-0907-8. PMID: (B)(6).

    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. DOI: 10.1007/S00402-009-0907-8.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, ON LITERATURE REVIEW "CEMENTLESS TOTAL HIP REPLACEMENT: A PROSPECTIVE CLINICAL STUDY OF THE EARLY FUNCTIONAL AND RADIOLOGICAL OUTCOMES OF THREE DIFFERENT HIP STEMS", ONE ASYMPTOMATIC PATIENT WHO HAD INITIALLY A SL-PLUS STEM IMPLANTED REVEALED A GREATER TROCHANTER APEX FRACTURE THAT COULD BE DETECTED AT THE SECOND POSTOPERATIVE EVALUATION (UNSPECIFIED TIME FRAME). NO REVISION SURGERY WAS REQUIRED DURING MEDICAL FOLLOW UPS WITHIN THE 12 POSTOPERATIVE MONTHS TIME FRAME. FURTHER INFORMATION ON THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1594910 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 Unknown Other