BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN SECTOR HA ACET CUP 58MM

    MDR report key: 3041968 · Received April 9, 2013

    Report

    Report Number
    1818910-2013-14478
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    October 6, 2011
    Report Date
    March 20, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    KWA
    PMA / PMN Number
    K031495
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION AND JUSTIFICATION STATUS: A REVIEW OF THE MANUFACTURING RECORDS AND THE COMPLAINTS DATABASE DID NOT HIGHLIGHT ANY ANOMALIES OR ANY PREVIOUS TRENDS FOR THIS ISSUE. NO PRODUCT OR FURTHER INFORMATION WAS RECEIVED AND SO NO FURTHER INVESTIGATION COULD BE CARRIED OUT. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION; IT SHALL BE ENTERED ONTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. SHOULD ADDITIONAL INFORMATION BE RECEIVED THEN THE COMPLAINT SHALL BE INVESTIGATED FURTHER.

    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.

    Additional Manufacturer Narrative · 1

    REVISED DUE TO PAIN PRIMARY SURGERY DATE (B)(6)2009 REVISION SURGERY DATE (B)(6)2011 THE REPORTED EVENT HAS BEEN EVALUATED AND WILL BE MONITORED. 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. 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

    REVISED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146379 PINN SECTOR HA ACET CUP 58MM HIP ACETABULAR CUP KWA DEPUY ORTHOPAEDICS, INC. 1818910 DX6LL1000

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention