BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DLT TS CER HD 12/14 36MM +5.0

    MDR report key: 3063818 · Received April 17, 2013

    Report

    Report Number
    1818910-2013-15507
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LZO
    PMA / PMN Number
    PK071830
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LOT CODES REQUIRED WERE NOT PROVIDED. MEDICAL RECORDS WERE RECEIVED AND REVIEWED. FROM A MEDICAL PERSPECTIVE, BASED ON THE INFORMATION AVAILABLE, THE COMPLAINT IS NOT PRODUCT RELATED. ALL HIP ARTHROPLASTY HAS A RISK OF DISLOCATION AND THE RISKS OF THE INDIVIDUAL ARE DUE TO AN UNPREDICTABLE COMBINATION OF PATIENT FACTORS, SURGICAL PROCESS, SURGICAL TECHNIQUE AND DEVICE RELATED INTERACTIONS. THE SURGEON IN THIS CASE, FELT STRONGLY THAT THE PATIENT¿S GLOBAL SOFT TISSUE LAXITY WAS A PROMINENT FACTOR. THE INVESTIGATION CAN DRAW NO FURTHER CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LOT CODES REQUIRED WERE NOT PROVIDED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. D. NO ADDITIONAL INFORMATION WAS OBTAINED. 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 AT THIS TIME. SHOULD THE PRODUCT OR 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS DISLOCATION AND TROCHANTERIC AVULSION.

    Description of Event or Problem · 1

    THE PATIENT HARM, DATE OF IMPLANTATION, AND PRODUCT CODE OF THE POLYETHYLENE LINER WERE UPDATED AND ADDED LAWYER, PATIENT MEDICAL HISTORY, AND LOT NUMBER OF THE CERAMIC HEAD AND POLY LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166065 DLT TS CER HD 12/14 36MM +5.0 FEMORAL HEAD LZO DEPUY ORTHOPAEDICS INC US 3253052

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention