BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE 300 ACET CUP 50MM

    MDR report key: 20334635 · Received September 30, 2024

    Report

    Report Number
    1818910-2024-20464
    Event Type
    Injury
    Date Received
    September 30, 2024
    Date of Event
    February 22, 2023
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    UDI-DI
    10603295008644
    PMA / PMN Number
    P070026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. PRODUCT DESCRIPTION: PINNACLE 300 ACET CUP 50MM. PRODUCT CODE: 121703050, LOT NUMBER: 183253, QUANTITY OF MANUFACTURED- (B)(4), DATE OF MANUFACTURING:1-DEC-2011, EXPIRY DATE: 31-DEC-2011. 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: PINNACLE 300 ACET CUP 50MM. PRODUCT CODE: 121703050, LOT NUMBER: 183253, QUANTITY OF MANUFACTURED- (B)(4), DATE OF MANUFACTURING:1-DEC-2011, EXPIRY DATE: 31-DEC-2011. DEVICE HISTORY REVIEW : A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [183253] NUMBER, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED.

    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
    1040501 PINNACLE 300 ACET CUP 50MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS LPH DEPUY ORTHOPAEDICS INC US 183253 10603295008644

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention APEX HOLE ELIM POSITIVE STOP| ASPHERE M SPEC 12/14 36 +1.5| CORAIL2 LAT COXA VARA SIZE 12| PINNACLE MTL INS NEUT36IDX50OD