BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASPHERE M SPEC 12/14 36 +1.5

    MDR report key: 20335761 · Received September 30, 2024

    Report

    Report Number
    1818910-2024-20471
    Event Type
    Injury
    Date Received
    September 30, 2024
    Date of Event
    February 22, 2023
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    UDI-DI
    10603295033929
    PMA / PMN Number
    K082585
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. PRODUCT DESCRIPTION- ASPHERE M SPEC 12/14 36 +1.5; PRODUCT CODE- 136551100; LOT NO- 3013522; QUANTITY OF MANUFACTURED- (B)(4); DATE OF MANUFACTURING- 01-OCT-2009; EXPIRY DATE- 31-OCT-2014. 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. DEVICE HISTORY LOT: PRODUCT DESCRIPTION- ASPHERE M SPEC 12/14 36 +1.5; PRODUCT CODE- 136551100; LOT NO- 3013522; QUANTITY OF MANUFACTURED- (B)(4); DATE OF MANUFACTURING- 01-OCT-2009; EXPIRY DATE- 31-OCT-2014. DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [3013522] NUMBER, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    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 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

    ON (B)(6) 2012, PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY DUE TO DEGENERATIVE JOINT DISEASE. ON (B)(6) 2023, PATIENT UNDERWENT A REVISION DUE TO PAIN AND LOSS OF FUNCTION SECONDARY TO METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    962829 ASPHERE M SPEC 12/14 36 +1.5 ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS KWA DEPUY ORTHOPAEDICS INC US 3013522 10603295033929

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention