BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN SECTOR W/GRIPTION 52MM

    MDR report key: 3012373 · Received March 20, 2013

    Report

    Report Number
    1818910-2013-04383
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    April 1, 2011
    Report Date
    February 1, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    K071784
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE ITS RELEASE FOR DISTRIBUTION. FROM A MEDICAL PERSPECTIVE, BASED ON THE LIMITED INFORMATION AVAILABLE TO BE REVIEWED, IT IS NOT POSSIBLE TO DETERMINE IF THE COMPLAINT IS PRODUCT RELATED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED.

    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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE TO PAIN AND VISIBLE SCRATCHES. **UPDATE** (B)(4) 2012 - LITIGATION PAPERS RECEIVED. THEY ALLEGE PAIN, SWELLING, INFLAMMATION, PSEUDOTUMORS, AND METALLOSIS. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. UPDATE: (B)(4) 2013 - PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. DOI: (B)(6) 2010. RECORDS INDICATE THAT THE PATIENT WAS REVISED AGAIN BECAUSE OF INFECTION ON (B)(6) 2011 RECORDS ARE AVAILABLE FOR FURTHER REVIEW. (RIGHT HIP) THE PATIENT WAS REVISED ON (B)(6) 2011 FOR PAIN AND IMPINGEMENT OF THE STEM AND CUP. THERE WAS POLY WEAR OF THE LINER WHICH WAS MOST LIKELY SECONDARY TO THE IMPINGEMENT SINCE IT WAS ONLY IMPLANTED 5 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115413 PINN SECTOR W/GRIPTION 52MM ACETABULAR SHELL LPH DEPUY ORTHOPAEDICS INC US UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR