BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AML MMA 10.5MM 6.3 IN STEM

    MDR report key: 2917647 · Received January 16, 2013

    Report

    Report Number
    1818910-2013-11014
    Event Type
    Injury
    Date Received
    January 16, 2013
    Date of Event
    December 21, 2012
    Report Date
    December 21, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK870699
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WAS REVISED TO ADDRESS OSTEOLYSIS, POLY WEAR, AND A STEM WHICH WAS BROKEN AND LOOSE PROXIMALLY. DOI 1990S - DOR (B)(6) 2012 (RIGHT HIP). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE FEMORAL STEM PRODUCT/LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE FOR THE ACETABULAR LINER AS THE LOT CODE REQUIRED WAS NOT PROVIDED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. C. 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). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE 755760 LOT CODE FOR IMPLANT FRACTURE AND DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. A COMPLAINT DATABASE SEARCH WAS NO POSSIBLE FOR THE REMAINING PRODUCT AND THE REQUIRED PRODUCT AND LOT CODE WAS NOT PROVIDED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. MEDICAL RECORDS AND X-RAYS WERE OBTAINED. THE REVIEW OF THE MEDICAL RECORDS CONFIRMS THE COMPLAINT OF OSTEOLYSIS (PRESENT IN BOTH THE PELVIS AND THE PROXIMAL FEMUR) AND A BROKEN FEMORAL STEM. THE STEM APPEARED TO BE WELL-FIXED IN THE BONE DISTALLY AND COMPLETELY UNSUPPORTED BY BONE PROXIMALLY AS A RESULT OF THE AMOUNT OF OSTEOLYSIS PRESENT. IT WOULD NOT BE UNLIKELY FOR THE PATIENT TO HAVE PAIN AS A RESULT OF THE BROKEN STEM AND OSTEOLYSIS. 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. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    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.IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE 755760 LOT CODE FOR IMPLANT FRACTURE AND DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. A COMPLAINT DATABASE SEARCH WAS NO POSSIBLE FOR THE REMAINING PRODUCT AND THE REQUIRED PRODUCT AND LOT CODE WAS NOT PROVIDED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. MEDICAL RECORDS AND X-RAYS WERE OBTAINED. THE REVIEW OF THE MEDICAL RECORDS CONFIRMS THE COMPLAINT OF OSTEOLYSIS (PRESENT IN BOTH THE PELVIS AND THE PROXIMAL FEMUR) AND A BROKEN FEMORAL STEM. THE STEM APPEARED TO BE WELL-FIXED IN THE BONE DISTALLY AND COMPLETELY UNSUPPORTED BY BONE PROXIMALLY AS A RESULT OF THE AMOUNT OF OSTEOLYSIS PRESENT. IT WOULD NOT BE UNLIKELY FOR THE PATIENT TO HAVE PAIN AS A RESULT OF THE BROKEN STEM AND OSTEOLYSIS. 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS OSTEOLYSIS, POLY WEAR, AND A STEM WHICH WAS BROKEN AND LOOSE PROXIMALLY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24467 AML MMA 10.5MM 6.3 IN STEM FEMORAL HIP STEM JDI DEPUY ORTHOPAEDICS, INC. 755760

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention