BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN. RT-PLUS MODULAR FEMORAL COMP.

    MDR report key: 13498465 · Received February 9, 2022

    Report

    Report Number
    9613369-2022-00028
    Event Type
    Injury
    Date Received
    February 9, 2022
    Date of Event
    November 18, 2021
    Report Date
    March 7, 2022
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS AG
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: CASE (B)(4). VERINGA, V., FRIEDL, W., BADULESCU, O. V., TUDOR, R., RADU, V., BODESCU, A., ... & SIRBU, P. D. (2021, NOVEMBER). MODULAR ROTATING-HINGE PROSTHESIS IN SEVERE HAEMOPHILIC VALGUS KNEE OSTEOARTHRITIS. CASE PRESENTATION. IN 2021 INTERNATIONAL CONFERENCE ON E-HEALTH AND BIOENGINEERING (EHB) (PP. 1-4). IEEE. DOI: 10.1109/EHB52898.2021.9657701.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFO IN: D, G, H RESULTS OF INVESTIGATION: IN THE LITERATURE ARTICLE OF VERINGA ET AL. 2021 [1], IT WAS REPORTED THAT, IN THE FIRST 10 DAYS AFTER A TOTAL KNEE ARTHROPLASTY WITH RT-PLUS MODULAR, THE PATIENT HAD SOFT TISSUE LESIONS AROUND THE SURGICAL APPROACH WITH BLISTERS AND LIMITED SKIN NECROSIS. THE INJURY HEALED UNDER STERILE DRESSING, ELASTIC BANDAGE AND CRYOTHERAPY, THEREFORE PATIENT´S OUTCOME IS RECOVERED. THE PART AND THE BATCH NUMBER OF THIS DEVICE ARE NOT KNOWN. THEREFORE, IT IS NOT POSSIBLE TO INVESTIGATE WHETHER THE REPORTED DEVICE MET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW WAS CONDUCTED AND THE CURRENT COMPLAINT IS IN LINE WITH THE POST MARKET SURVEILLANCE REPORT. THE REPORTED FAILURE MODE MIGHT OCCUR IN SOME CASES, WHICH IS STATED AS A SIDE EFFECT IN THE IFU LIT. NO. 12.24 ED. 03/21. NONE OF ANY PRIOR ESCALATION ACTIONS ARE RELATED TO THE REPORTED ISSUE. THE SEVERITY AND THE FAILURE MODE ARE COVERED THROUGH OUR RISK MANAGEMENT. AS NO DEVICE WAS RECEIVED FOR INVESTIGATION, A VISUAL INSPECTION COULD NOT BE PERFORMED. BASED ON THE PROVIDED MEDICAL INFORMATION, A THOROUGH CONCLUSION CANNOT BE DONE DUE TO LIMITED INFORMATION. BASED ON OUR INVESTIGATIONS, THE FAILURE MODE AND THE RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED EVENT CANNOT BE CONFIRMED. DUE TO INSUFFICIENT INFORMATION, IT IS NOT POSSIBLE TO SPECULATE ABOUT FACTORS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. TO DATE, NO FURTHER ACTIONS WILL BE TAKEN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS COMPLAINT WILL BE REASSESSED. SMITH AND NEPHEW WILL MONITOR THE DEVICES FOR FURTHER SIMILAR ISSUES. [1]: VERINGA, VLAD & FRIEDL, WILHELM & BADULESCU, OANA & TUDOR, RAZVAN & RADU, VALENTIN & BODESCU, ADRIAN & GHEORGHE, SOFRON & SIRBU, PAUL-DAN. (2021). MODULAR ROTATING-HINGE PROSTHESIS IN SEVERE HAEMOPHILIC VALGUS KNEE OSTEOARTHRITIS. CASE PRESENTATION. 1-4. 10.1109/EHB52898.2021.9657701.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON LITERATURE REVIEW "MODULAR ROTATING-HINGE PROSTHESIS IN SEVERE HAEMOPHILIC VALGUS KNEE OSTEOARTHRITIS. CASE PRESENTATION", IN THE FIRST 10 DAYS AFTER TKA WITH RT-PLUS MODULAR, THE PATIENT HAD SOFT TISSUE LESIONS AROUND THE SURGICAL APPROACH WITH BLISTERS AND LIMITED SKIN NECROSIS. THE INJURY HEALED UNDER STERILE DRESSING, ELASTIC BANDAGE AND CRYOTHERAPY, THEREFORE PATIENT´S OUTCOME IS RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1087334 UNKN. RT-PLUS MODULAR FEMORAL COMP. PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH SMITH & NEPHEW ORTHOPAEDICS AG UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R| H