BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE 300 ACET CUP 52MM

    MDR report key: 2878457 · Received December 18, 2012

    Report

    Report Number
    1818910-2012-29200
    Event Type
    Injury
    Date Received
    December 18, 2012
    Report Date
    July 25, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LPH
    PMA / PMN Number
    K000306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE LOT CODES 1895734 AND Z3XDE1. A SEARCH OF THE COMPLAINT DATABASE SEARCH FINDS ADDITIONAL REPORTED INCIDENTS AGAINST LOT CODE 1951101 SINCE ITS RELEASE FOR DISTRIBUTION; HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    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. NOT RETURNED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: ON OR ABOUT (B)(6) 2005, PATIENT WAS IMPLANTED WITH A DEPUY PINNACLE MOM HIP ON HER RIGHT SIDE. AFTER THE SURGERY, PATIENT EXPERIENCED ELEVATED LEVELS OF COBALT-CHROMIUM IN HER BLOOD, SEVERE PAIN, DISCOMFORT, AND INFLAMMATION IN HER LEFT THIGH AND GROIN. SHE ALSO EXPERIENCED A POPPING AND SNAPPING SENSATION IN HER HIP JOINT WHEN WALKING OR MOVING TO AND FROM A SITTING POSITION. SHE WAS REVISED IN (B)(6) 2010. **UPDATE** (B)(6) 2012-MEDICAL RECORDS RECEIVED . MEDICAL RECORDS INDICATE PATIENT WAS REVISED DUE TO PAIN. RECORDS INDICATED A LEG LEGTH DISCREPANCY AND CUP LOOSENING. THERE WAS SCRATCHES AND LOOSENING NOTED ON THE FEMORAL HEAD HOWEVER DUE TO THE FIBERWIRE IN THE JOINT ITSELF. THE CUP WAS ADDED TO COMPLAINT AND PART/LOT UPDATED.

    Description of Event or Problem · 1

    IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES ABDUCTOR MUSCLE REPAIR. ADDED REVISION HOSPITAL, REVISION SURGEON, LAWYER IN THE ASSOCIATED CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE 300 ACET CUP 52MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS LPH DEPUY ORTHOPAEDICS, INC. 1818910 Z3XDE1000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention