BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM M HEAD 36MM +9

    MDR report key: 2982651 · Received February 28, 2013

    Report

    Report Number
    1818910-2013-12927
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    February 12, 2013
    Report Date
    October 4, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    PK851422
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A 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 THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION 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

    THE 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

    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

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES FOR THE PROVIDED PRODUCT AND LOT COMBINATIONS. X-RAY(S) WERE OBTAINED AND REVIEWED BY A MEDICAL PROFESSIONAL. IT IS NOT POSSIBLE TO DRAW ANY CONCLUSIONS FROM THE SUPPLIED RADIOGRAPHS. 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 ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES FOR THE PROVIDED PRODUCT AND LOT COMBINATIONS. X-RAY(S) WERE OBTAINED AND REVIEWED BY A MEDICAL PROFESSIONAL. IT IS NOT POSSIBLE TO DRAW ANY CONCLUSIONS FROM THE SUPPLIED RADIOGRAPHS. 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). (B)(4) USED TO CAPTURE THE BLOOD HEAVY METAL INCREASED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED BILATERALLY TO ADDRESS METALLOSIS AND MINIMAL OSTEOLYSIS.

    Description of Event or Problem · 1

    UPDATE 10/4/16 MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE METAL ION LEVEL PROVIDED WERE AT NON-REPORTABLE LEVELS. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING INVESTIGATION.

    Description of Event or Problem · 1

    PPF ALLEGES ELEVATED METAL IONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88674 S-ROM M HEAD 36MM +9 FEMORAL HEAD JDI DEPUY ORTHOPAEDICS INC US 2145715

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention