BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN FEM HEAD AARAU METAL

    MDR report key: 12823628 · Received November 16, 2021

    Report

    Report Number
    9613369-2021-00408
    Event Type
    Injury
    Date Received
    November 16, 2021
    Date of Event
    July 1, 2018
    Report Date
    January 6, 2022
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS AG
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: THE STUDY OF XING ET. AL. [1] REPORTS ONE CASE OF SEVERE WEAR AND MULTIPLE PSEUDOTUMOR FORMATION DUE TO REVISION FOR CERAMIC HEAD BREAKAGE. AS THIS IS A LITERATURE COMPLAINT, THE PARTS, USED IN TREATMENT, WERE NOT RETURNED FOR INVESTIGATION. IT IS REPORTED, THAT THE PATIENT SUFFERED FROM A PSEUDO TUMOR FOLLOWING THE IMPLANTATION OF A METAL BALL HEAD AFTER A CERAMIC COMPONENT FRACTURE. 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. ACCORDING TO IFU LIT. NO. 12.23 ED. 03/21 A METAL BALL HEAD SHOULD NOT BE IMPLANTED AFTER A FRACTURE OF A CERAMIC COMPONENT. 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. NO PATIENT INFORMATION NOR ANY OTHER MEDICAL DOCUMENTATION WAS PROVIDED, THEREFORE, A THOROUGH MEDICAL INVESTIGATION COULD NOT BE PERFORMED. REVIEW OF PAST CORRECTIVE ACTIONS WAS PERFORMED. NO FURTHER ESCALATION IS REQUIRED. BASED ON OUR INVESTIGATIONS THE FAILURE MODE AND THE RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED EVENT CAN BE CONFIRMED REVIEWING THE CASE STUDY. THE ROOT CAUSE IS ATTRIBUTED TO AN OFF-LABEL USE. 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]: XING, D., YANG, C., LI, R. ET AL. SEVERE WEAR AND MULTIPLE PSEUDOTUMOR FORMATION DUE TO REVISION FOR CERAMIC HEAD BREAKAGE AFTER CERAMIC-ON-CERAMIC TOTAL HIP ARTHROPLASTY: A CASE REPORT. BMC MUSCULOSKELET DISORD 20, 332 (2019). HTTPS://DOI.ORG/10.1186/S12891-019-2722-X.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    ON THE LITERATURE ARTICLE NAMED "SEVERE WEAR AND MULTIPLE PSEUDOTUMOR FORMATION DUE TO REVISION FOR CERAMIC HEAD BREAKAGE AFTER CERAMIC-ON-CERAMIC TOTAL HIP ARTHROPLASTY: A CASE REPORT", THE AUTHORS OF THE STUDY REPORTED THAT, 8 MONTHS AFTER THE FIRST REVISION SURGERY WHEN A MOP SYSTEM WAS IMPLANTED IN THE PATIENT´S RIGHT HIP (COVERED UNDER (B)(4)), THE PATIENT WAS ADMITTED AGAIN TO THE HOSPITAL WITH LOW FEVER, LOSS OF APPETITE AND WEIGHT LOSS. X-RAY SHOWED HUGE SOFT TISSUE MASS AROUND RIGHT HIP PROSTHESIS AND COMPUTED TOMOGRAPHIC (CT) SCAN SHOWED A MASS EXTENDING TO THE PELVIS WITHOUT BONE DESTRUCTION. SERUM ION CONCENTRATIONS (COBALT, CHROMIUM AND TITANIUM) WERE SIGNIFICANTLY ELEVATED. A REVISION SURGERY WAS PERFORMED AND EXTENSIVE METALLOSIS AND DARK GRAY TISSUE WAS VISIBLE AROUND THE JOINT. THE ACETABULAR SHELL AND FEMORAL STEM WERE WELL FIXED, AND THEREFORE, THESE COMPONENTS WERE RETAINED. A SEVERE WEAR WAS NOTED AROUND THE METAL HEAD AND POLYETHYLENE LINER, WHICH WERE EXCHANGED. THE TAPER EXHIBITED WEAR WITHOUT FRACTURE, THEREFORE A TITANIUM SLEEVE (ZIMMER) WAS IMPLANTED. SYNOVECTOMY AND EXTENSIVE DEBRIDEMENT WERE CONDUCTED BEFORE CLOSING THE WOUND. THE OUTCOME OF THE PATIENT REMAINS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1720081 UNKN FEM HEAD AARAU METAL PROSTHESIS,HIP,SEMICONSTRAINED,METALCERAMICPOLYMER,CEMENTEDORNONPOROUS LZO SMITH & NEPHEW ORTHOPAEDICS AG UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male UNKN. EP-FIT PLUS SHELL