BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM*SCREW,6.5MM DIA,20MM LG

    MDR report key: 3091023 · Received May 3, 2013

    Report

    Report Number
    1818910-2013-16493
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    March 18, 2013
    Report Date
    April 4, 2013
    Manufacturer
    1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC
    Product Code
    LPH
    PMA / PMN Number
    PK951000
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    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. PATIENT WAS REVISED TO ADDRESS POLY WEAR DEBRIS AND OSTEOLYSIS. DOI (B)(6) 1995 - DOR (B)(6) 2013 (HIP). UPDATE: 04/04/2013. PATIENT'S MEDICAL RECORDS WERE RECEIVED. RECORDS INDICATE THE PATIENT WAS ALSO REVISED TO ADDRESS PAIN. UPON REVISION THE CUP WAS FOUND TO BE LOOSE. ADDING THE CUP AND SCREWS FOR PAIN AND LOOSENING. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. D. OPERATIVE NOTES WERE OBTAINED CONFIRMING THE COMPLAINT. IT WOULD NOT HOWEVER BE UNREASONABLE TO FIND POLY MATERIAL WEAR AFTER THE LENGTH OF TIME REPORTED AS IMPLANTED. BASED ON THE INVESTIGATION THE NEED FOR CORRECTIVE ACTION IS 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 POLY WEAR DEBRIS AND OSTEOLYSIS. **UPDATE** (B)(6) 2013 - PATIENT'S MEDICAL RECORDS WERE RECEIVED. RECORDS INDICATE THE PATIENT WAS ALSO REVISED TO ADDRESS PAIN. UPON REVISION THE CUP WAS FOUND TO BE LOOSE. ADDING THE CUP AND SCREWS FOR PAIN AND LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193884 S-ROM*SCREW,6.5MM DIA,20MM LG SCREW LPH 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC SA101086

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention