BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX54OD

    MDR report key: 2941105 · Received February 4, 2013

    Report

    Report Number
    1818910-2013-11786
    Event Type
    Injury
    Date Received
    February 4, 2013
    Report Date
    January 7, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    PMA / PMN Number
    PK003523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE AND/OR DHR REVIEW WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE LOT CODES 2384800 AND BE1E51. A SEARCH OF THE COMPLAINT DATABASE SEARCH FINDS ADDITIONAL REPORTED INCIDENTS AGAINST LOT CODES 2305783 AND 2386757 SINCE THEIR 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 ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    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 ALLEGES THAT PATIENT EXPERIENCED PAIN, DISCOMFORT, AND INFLAMMATION IN THIGH AND GROIN. PATIENT ALSO EXPERIENCED A POPPING AND SNAPPING SENSATION IN HIP JOINT WHEN WALKING OR MOVING TO AND FROM A SITTING POSITION.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT PATIENT EXPERIENCED PAIN, DISCOMFORT, AND INFLAMMATION IN THIGH AND GROIN. PATIENT ALSO EXPERIENCED A POPPING AND SNAPPING SENSATION IN HIP JOINT WHEN WALKING OR MOVING TO AND FROM A SITTING POSITION. UPDATE (B)(4) 2013- PFS AND MEDICAL RECORDS RECEIVED. PART/LOT WAS PROVIDED IT WAS CONFIRMED THAT THE PATIENT WAS REVISED ON (B)(6) 2013. OPERATIVE NOTES INDICATED THAT THE PATIENT WAS REVISED DUE TO PAIN AND A LOOSE CUP AND STEM. THE CUP AND STEM HAVE NOW BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47168 PINNACLE MTL INS NEUT36IDX54OD METAL LINER KWA DEPUY ORTHOPAEDICS INC US 2384800

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other