BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM M HEAD 36MM +3

    MDR report key: 2924626 · Received January 22, 2013

    Report

    Report Number
    1818910-2013-11280
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    January 14, 2013
    Report Date
    November 26, 2014
    Manufacturer
    DEPUY INTL., LTD.
    Product Code
    JDI
    PMA / PMN Number
    K120599
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. THIS COMPLAINT IS CONSIDERED CLOSED.

    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. 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

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. ADDITIONAL MEDICAL RECORDS WERE RECEIVED AND REVIEWED. PREVIOUS REVIEW OF PROVIDED PATIENT X-RAYS REVEALS STEM SLIGHTLY IN VARUS POSITION. CUP INCLINATION WAS DIFFICULT TO REVIEW DUE TO THE IMPLANT POSITION, WITHOUT THE IMPLANT IT IS NOT POSSIBLE TO CONFIRM IF THIS LEAD TO INCREASED WEAR OF THE DEVICE. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN IDENTIFIED. 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

    ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND 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 LINER AS THE LOT CODE REQUIRED WAS NOT PROVIDED. AN X-RAY AND PICTURES OF TISSUE WERE RECEIVED WITH THE COMPLAINT. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. C. NO FURTHER ADDITIONAL INFORMATION WAS AVAILABLE. 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 ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. ADDITIONAL MEDICAL RECORDS WERE RECEIVED BUT NOT REVIEWED PER NC ((B)(4)). PREVIOUS REVIEW OF PROVIDED PATIENT X-RAYS REVEALS STEM SLIGHTLY IN VARUS POSITION. CUP INCLINATION WAS DIFFICULT TO REVIEW DUE TO THE IMPLANT POSITION, WITHOUT THE IMPLANT IT IS NOT POSSIBLE TO CONFIRM IF THIS LEAD TO INCREASED WEAR OF THE DEVICE. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN IDENTIFIED. 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS A REACTION TO METAL.

    Description of Event or Problem · 1

    UPDATE (B)(6) 2014 - PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE INDICATED OSTEOLYSIS, PATHOLOGIC GREATER TROCHANTER FRACTURE THAT IS HEALING, METALLOSIS, METAL DEBRIS AROUND THE SCREW, REACTIVE SOFT TISSUE MASS, CORROSION ON THE TRUNNION, , THREADING AT THE SCREW/CUP INTERFACE, AND THE SCREW WAS PROUD AND HAD A DEFORMATION AT THE HEAD. THE STEM IS BEING ADDED FOR THE ALLEGED HIGH METAL IONS (NO LAB RESULTS PROVIDED). THERE WAS NO MENTION OF A LOOSE CUP AS PREVIOUSLY MENTIONED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30053 S-ROM M HEAD 36MM +3 FEMORAL HEAD JDI DEPUY INTL., LTD. YFF46

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention