BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM*LINR LSER,10 DEG,32MM C

    MDR report key: 2142828 · Received June 23, 2011

    Report

    Report Number
    1818910-2011-11303
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 2, 2011
    Manufacturer
    DEPUY IRELAND
    Product Code
    KWA
    PMA / PMN Number
    K924492
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

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

    Additional Manufacturer Narrative · 1

    **UPDATE: THIS IS A CLINICAL PATIENT, REPORT STATES THE PATIENT HAD POLY WEAR, PART/LOT INFORMATION WAS PROVIDED AND THE DOI: (B)(6) 2003. THE DEVICE ASSOCIATED WITH THIS REPORT WAS STILL NOT RETURNED. REVIEW OF THE PROVIDED DEVICE RECORDS DID NOT REVEAL ANY RELATED DEVIATIONS OR ANOMALIES. PER THE REPORTING BY THE DEPUY CLINICAL TEAM, ONLY PATIENT DEMOGRAPHICS ARE AVAILABLE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. 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 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

    UPDATE: THIS IS A CLINICAL PATIENT, REPORT STATES THE PATIENT HAD POLY WEAR, PART/LOT INFORMATION WAS PROVIDED AND THE DOI: (B)(6) 2003. THE DEVICE ASSOCIATED WITH THIS REPORT WAS STILL NOT RETURNED. REVIEW OF THE PROVIDED DEVICE RECORDS DID NOT REVEAL ANY RELATED DEVIATIONS OR ANOMALIES. PER THE REPORTING BY THE DEPUY CLINICAL TEAM, ONLY PATIENT DEMOGRAPHICS ARE AVAILABLE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. 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 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

    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 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.

    Description of Event or Problem · 1

    UPDATE: THIS IS A CLINICAL PATIENT, REPORT STATES THE PATIENT HAD POLY WEAR, PART/LOT INFORMATION WAS PROVIDED AND THE DOI: (B)(6) 2003.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS A FRACTURED LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S-ROM*LINR LSER,10 DEG,32MM C HIP LINER KWA DEPUY IRELAND NA 1041080

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention