BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX HOLE ELIM POSITIVE STOP

    MDR report key: 11425412 · Received March 5, 2021

    Report

    Report Number
    1818910-2021-04528
    Event Type
    Malfunction
    Date Received
    March 5, 2021
    Date of Event
    February 22, 2021
    Report Date
    February 22, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    K963309
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, 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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # : PC-(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 : THROUGH PRODUCT TRENDING IT IS RECOGNIZED THAT AN INCREASE IN THIS ALLEGATION HAS BEEN IDENTIFIED. NONCONFORMANCE REPORTS (NR) (B)(4), APEX HOLE ELIMINATOR, (NR) (B)(4) AND (NR) (B)(4) ACETABULAR CUP, HAVE BEEN ESTABLISHED TO FURTHER INVESTIGATE THIS ISSUE. PER THAT INVESTIGATIVE PROCESS IT WAS DETERMINED THE ROOT CAUSE IS RELATED TO MANUFACTURE OF THE ACETABULAR CUP, NOT THE APEX HOLE ELIMINATOR. MRE NOT PERFORMED.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE APEX HOLE ELIMINATOR WENT THROUGH CUP. SURGICAL DELAY: 30MINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318879 APEX HOLE ELIM POSITIVE STOP HOLE ELIMINATOR LPH DEPUY ORTHOPAEDICS INC US D21010308

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention PINN SECTOR W/GRIPTION 50MM| UNK HIP ACETABULAR HOLE ELIMINATOR