BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM M HEAD 36MM +0

    MDR report key: 3201893 · Received July 2, 2013

    Report

    Report Number
    1818910-2013-20378
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 25, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    PK120599
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE PROVIDED PRODUCT/LOT COMBINATIONS REVEALED NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. D. X-RAYS AND DEMOGRAPHICS WERE RECEIVED BUT DO NOT IDENTIFY A ROOT CAUSE. 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    PATIENT WAS REVISED TO ADDRESS PAIN AND ELEVATED METAL ION LEVELS IN BLOOD. TISSUE WAS STAINED FROM METAL WEAR DEBRIS. OSTEOLYSIS WAS ALSO REPORTED. DOI (B)(6) 2005 - DOR (B)(6) 2013 (RIGHT HIP). (B)(4) 2013- X-RAYS AND PATIENT DEMOGRAPHICS WERE RECEIVED. X-RAYS WERE ATTACHED TO COMPLAINT. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE PROVIDED PRODUCT/LOT COMBINATIONS REVEALED NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. D. X-RAYS AND DEMOGRAPHICS WERE RECEIVED BUT DO NOT IDENTIFY A ROOT CAUSE. 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. 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 PAIN AND ELEVATED METAL ION LEVELS IN BLOOD. TISSUE WAS STAINED FROM METAL WEAR DEBRIS. OSTEOLYSIS WAS ALSO REPORTED.

    Description of Event or Problem · 1

    UPDATE REC'D 1/14/2016 - LITIGATION PAPERS ALLEGE THE PATIENT EXPERIENCED COMPLICATIONS, INCLUDING, BUT NOT NECESSARILY LIMITED TO PAIN, DISCOMFORT, DIFFICULTY AMBULATING, AND METALLOSIS.

    Description of Event or Problem · 1

    UPDATE 4/19/16- PFS AND MEDICAL RECORDS RECEIVED. PFS AND MEDICAL RECORDS REVIEWED FOR MDR REPORTABILITY. PFS REPORTED EXTREME PAIN, DISFIGUREMENT, PERMANENT DAMAGE TO HIP AREA, MOBILITY AND RANGE OF MOTION LOSS, AND MENTAL ANGUISH. MEDICAL RECORDS REPORTED PAIN AND SQUEAKING. REVISION SURGICAL NOTE REPORTED SIGNIFICANT BLACK STAINING OF ALL SOFT TISSUES AND BLACKENED MATERIAL SURROUNDING THE ENTIRE OUTSIDE OF ACETABULAR CUP. SURGEON NOTED THAT BECAUSE OF ELEVATED METAL IONS CUP WAS REVISED. METAL ION LAB RESULTS WERE GREATER THAN 7 PARTS PER BILLION. STEM AND CUP ADDED FOR ELEVATED METAL IONS. THE COMPLAINT WAS UPDATED ON: MAY 12, 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301301 S-ROM M HEAD 36MM +0 FEMORAL HEAD JDI DEPUY ORTHOPAEDICS INC US 1933336

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention