BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM M HEAD 36MM +0

    MDR report key: 3082818 · Received April 29, 2013

    Report

    Report Number
    1818910-2013-16200
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    April 19, 2013
    Manufacturer
    8010379 DEPUY INTL., LTD.
    Product Code
    JDI
    PMA / PMN Number
    PK851422
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A DUPLICATE REPORT OF 1818910-2013-17321. THIS REPORT, 1818910-2013-16200 WILL BE KEPT FOR INVESTIGATION PURPOSES. A SEPARATE FOLLOW-UP REPORT WILL BE SUBMITTED TO REJECT 1818910-2013-17321.

    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

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. THE INITIAL REPORTING STATED NO ADDITIONAL INVESTIGATIONAL INPUTS WERE AVAILABLE. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY 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

    CLINICAL REPORT STATES THE PATIENT HAD SEVERE PAIN, AND SIGNIFICANT PROGRESSIVE OSTEOLYSIS TO THE PROXIMAL FEMUR. CT SCAN AND METAL ION LEVELS CHECK WAS COMPLETED ON THE PATIENT. ADDITIONAL INFORMATION RECEIVED FROM CLINICAL STATES THE COBALT AND CHROMIUM LEVELS TO BOTH BE LESS THAN 1.0 AND THERE WAS NO OSTEOLYSIS SEEN PER THE CT SCAN. ** UPDATE ** 04/19/2013 - IT HAS BEEN REPORTED THAT THE PATIENT WAS REVISED ON (B)(6) 2013 TO ADDRESS PAIN AND OSTEOLYSIS IN THE PROXIMAL FEMUR. THE LINER AND HEAD WERE REMOVED. BECAUSE THE PATIENT HAS NOW BEEN REVISED, THE MDR DECISION WILL BE CHANGED FROM MDR-NO TO MDR-YES FOR THE LINER AND HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185621 S-ROM M HEAD 36MM +0 FEMORAL HEAD JDI 8010379 DEPUY INTL., LTD. 1912804

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention