BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE TIBIAL INSERT

    MDR report key: 21875276 · Received April 21, 2025

    Report

    Report Number
    1818910-2025-06001
    Event Type
    Injury
    Date Received
    April 21, 2025
    Date of Event
    March 17, 2025
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEPUY ORTHOPAEDICS IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY ORTHOPAEDICS HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY ORTHOPAEDICS OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY ORTHOPAEDICS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11 ADDITIONAL NARRATIVE: A1: (B)(6). D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. D4: REPORTED LOT NUMBER 3943550 THE DEVICE LOT NUMBER IS UNKNOWN, THEREFORE A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. IF THE LOT/SERIAL NUMBER BECOMES AVAILABLE, THE RECORD WILL BE RE-ASSESSED. NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT/LOT NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    SUBJECT ID: (B)(5). STUDY NO: OASIS PROD. CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ PAIN/STIFFNESS DEVICE AND PROCEDURE (RELATEDNESS): DEVICE RELATED: NO INFORMATION PROVIDED PROCEDURE RELATED: NO INFORMATION PROVIDED DATE OF EVENT: (B)(6) 2025 DATE OF IMPLANT: NO INFORMATION PROVIDED DATE OF REVISION: (B)(6) 2025 DEVICE LOCATION: LEFT. TREATMENT/IMPACT: REVISION COMPONENTS REMOVED FEMORAL WERE DEPUY SYNTHES COMPONENTS REMOVED DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 150440106 LOT NUMBER: M7665Y COMPONENT TYPE: FEMORAL DESCRIPTION: ATTUNE REVISION CRS FEMORAL SIZE 6 LEFT CEMENTED. CATALOG NUMBER: 545050501 LOT NUMBER: 4515971 COMPONENT TYPE: CEMENT DESCRIPTION: SMARTSET CEMENT WITH GENTAMICIN 40G. CATALOG NUMBER: 545050501 LOT NUMBER: 4515971 COMPONENT TYPE: CEMENT DESCRIPTION: SMARTSET CEMENT WITH GENTAMICIN 40G. CATALOG NUMBER: 154706001 LOT NUMBER: M7814N COMPONENT TYPE: ACC DESCRIPTION: ATTUNE REVISION DISTAL FEMORAL AUGMENT SIZE 6 4MM. CATALOG NUMBER: 151214050 LOT NUMBER: D24100109 COMPONENT TYPE: STEM DESCRIPTION: ATTUNE REVISION CEMENTED STEM 14 MM X 50 MM. CATALOG NUMBER: 151401200 LOT NUMBER: 4360335 COMPONENT TYPE: CONE DESCRIPTION: REVISION FEMORAL CONE MEDIUM. CATALOG NUMBER: 151710612 LOT NUMBER: 3943550 COMPONENT TYPE: INSERT DESCRIPTION: ATTUNE REVISION CRS ROTATING PLATFORM INSERT SIZE 6 12 MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1161277 UNKNOWN KNEE TIBIAL INSERT KNEE TIBIAL INSERT JWH DEPUY IRELAND - 9616671

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention