BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +1.5

    MDR report key: 2244864 · Received August 24, 2011

    Report

    Report Number
    1818910-2011-16023
    Event Type
    Injury
    Date Received
    August 24, 2011
    Report Date
    July 25, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    JDI
    PMA / PMN Number
    K980513
    Removal / Correction Number
    NA
    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

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES REQUIRED WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFO AVAILABLE. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATIONS CLOSED AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFO TO BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS BEEN REOPENED DUE TO RECEIVING PART AND LOT NUMBER. DEPUY WILL NOTIFY THE FDA WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: ON OR ABOUT (B)(6) 2005, PT WAS IMPLANTED WITH A DEPUY PINNACLE MOM HIP ON HER RIGHT SIDE. AFTER THE SURGERY, PT 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.

    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)(4) 2012 - MEDICAL RECORDS RECEIVED . MEDICAL RECORDS INDICATE PATIENT WAS REVISED DUE TO PAIN. RECORDS INDICATED A LEG LENGTH 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. **UPDATE**(B)(4) 2013 - UPON REVIEW OF MEDICAL RECORDS BY A MEDICAL PROFESSIONAL, PART/LOT WAS IDENTIFIED. THE COMPLAINT AND ASSOCIATED EMDRS HAVE BEEN UPDATED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION.

    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 ARTICULEZE M HEAD 36MM +1.5 ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS JDI DEPUY ORTHOPAEDICS, INC. 1818910 NA 1951101

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention