BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM M HEAD 36 +0

    MDR report key: 2870831 · Received December 12, 2012

    Report

    Report Number
    1818910-2012-28191
    Event Type
    Injury
    Date Received
    December 12, 2012
    Report Date
    March 6, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    K851422
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH 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 IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO CATALOG AND LOT #. UPDATE: (B)(4) 2013 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED BY INVOICE SEARCH. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. THE INVESTIGATION IS ONGOING. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    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 REPORTED PART AND LOT CODE COMBINATIONS. THE PART AND LOT CODE COMBINATION WAS NOT PROVIDED FOR THE POLY LINER. 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.

    Description of Event or Problem · 1

    MAUDE REPORT (B)(4)) VOLUNTARILY SUBMITTED BY PATIENT STATES HE WAS REVISED BILATERALLY FROM POLY TO METAL LINER TO ADDRESS PAIN, AND THAT HE IS STILL EXPERIENCING PAIN AND INSTABILITY. **UPDATE** (B)(4) 2012 - LITIGATION PAPERS RECEIVED. IT IS ALLEGED THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, AND A POPPING/SNAPPING SENSATION. TWO FEMORAL HEADS AND TWO METAL LINERS HAVE BEEN REPORTED. THE DOI FOR THE LEFT SIDE (POLY) WAS UPDATED, (B)(6) 2012. THE DOI AND DOR ARE UNKNOWN FOR THE METAL LINERS AND FEMORAL HEADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S-ROM M HEAD 36 +0 TOTAL HIP REPLACEMENT JDI DEPUY ORTHOPAEDICS INC US YFG64

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R