BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE SECTOR II CUP 50MM

    MDR report key: 14452444 · Received May 20, 2022

    Report

    Report Number
    1818910-2022-09183
    Event Type
    Malfunction
    Date Received
    May 20, 2022
    Date of Event
    May 5, 2022
    Report Date
    May 19, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    UDI-DI
    10603295009818
    PMA / PMN Number
    P070026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT ==> A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 121722050 LOT NUMBER 9536973 1) QUANTITY MANUFACTURED: (B)(4) 2) DATE OF MANUFACTURE: 10-JUN-2020 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: 1 NON-CONFORMANCE ASSOCIATED WITH THIS LOT: NR-0152452 IS RELATED TO UNDERSIZE MINOR THREAD DIAMETER ON THE APEX HOLE OF PINNACLE CUPS WHICH RESULTED IN A TREND OF COMPLAINTS FOR HOLE ELIMINATORS PASSING THROUGH THE APEX HOLE OF THE CUP. THIS LOT 9536973 IS PART OF THE BOUNDING OF THAT NR-0152452. THERE IS CORRELATION BETWEEN THIS NONCONFORMANCE AND THE FAILURE MODE OF THE COMPLAINT. 4) EXPIRY DATE: 31-MAY-2030 5) IFU REFERENCE: 090200701

    Description of Event or Problem · 0

    INTRAOPERATIVELY THE HOLE ELIMINATOR SLIPPED THROUGH THE THE CUP´S HOLE. IT DID NOT STOP LIKE IT SHOULD.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED: A. WAS/WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT DUE TO THIS EVENT? -> NO B. WHAT IS THE AFFECTED SIDE INVOLVED IN THIS EVENT? LEFT OR RIGHT? -> RIGHT C. WAS THERE A SURGICAL DELAY? IF YES, WHAT WAS THE DURATION OF THE DELAY? -> NO

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1190002 PINNACLE SECTOR II CUP 50MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS LPH DEPUY ORTHOPAEDICS INC US 1217-22-050 9536973 10603295009818

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown APEX HOLE ELIM POSITIVE STOP