BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BROACH

    MDR report key: 2937324 · Received January 31, 2013

    Report

    Report Number
    1818910-2013-00699
    Event Type
    Injury
    Date Received
    January 31, 2013
    Date of Event
    December 5, 2011
    Report Date
    March 25, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    K012364
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL REPORTS FOR THE LOT CODES 2927609, 2951142, 2982947, AND (B)(4). A SEARCH OF THE COMPLAINT DATABASE SEARCH FINDS TWO ADDITIONAL REPORTED INCIDENT AGAINST LOT CODE 2969774 SINCE ITS RELEASE FOR DISTRIBUTION; HOWEVER, A PREVIOUS 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

    *UPDATE: 3/25/2013 SALES REP REPORTS THAT THE PATIENT WAS REVISED BECAUSE OF PAIN, METAL ION LEVELS ELEVATED. DOR: (B)(6) 2013 (LEFT HIP). NO NEW INFORMATION WAS RECEIVED THAT WOULD CHANGE THE INVESTIGATIONAL RESULTS.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PATIENT EXPERIENCED SEVERE PAIN AND DISCOMFORT. **PATIENT IS A RESIDENT OF (B)(6). UPDATE: 1/8/2013 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. RECORDS INDICATE THAT DURING THE RIGHT HIP SURGERY THE FEMUR WAS FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42122 UNKNOWN BROACH TOTAL HIP REPLACEMENT LPH DEPUY ORTHOPAEDICS INC US UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other