BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN SECTOR HA ACET CUP 54MM

    MDR report key: 4812759 · Received June 2, 2015

    Report

    Report Number
    1818910-2015-22513
    Event Type
    Injury
    Date Received
    June 2, 2015
    Date of Event
    August 28, 2007
    Report Date
    May 13, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    PK031495
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. 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. CORRECTIVE ACTION WAS NOT INDICATED.DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN. UPDATE: 5/13/2015 - PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE INDICATED SUBLUXATION AND MALPOSITIONED CUP. PART/LOT IS BEING UPDATED FOR THE HEAD AND LINER AND THE CUP IS BEING ADDED TO THE COMPLAINT. THE COMPLAINT WAS UPDATED ON: 6/2/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357016 PINN SECTOR HA ACET CUP 54MM HIP ACETABULAR CUP LPH DEPUY ORTHOPAEDICS INC US Y22BK1000

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention