BEUDAMED
    FDA Adverse Event Summary report: N

    RSP SHOULDER

    MDR report key: 3000290 · Received March 12, 2013

    Report

    Report Number
    1644408-2013-00145
    Date Received
    March 12, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY ON (B)(6) 2013 WAS DUE TO AN INFECTION. THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2012. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. THERE WAS NO INFORMATION SUBMITTED WITH THIS COMPLAINT ABOUT ANY PATIENT ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRADICTIONS THAT MAY HAVE CONTRIBUTED TO AN INFECTION. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS NOT RETURNED TO DJO SURGICAL FOR EXAMINATION. THE DEVICE HISTORY RECORDS FOR THE REPORTED COMPONENTS INVOLVED WERE EXAMINED. A REVIEW OF THE STERILIZATION RECORDS SHOW THAT THE REPORTED DEVICES HAD ALL RECEIVED AN ADEQUATE (B)(4) STERILIZATION DOSE AND WERE WITHIN THEIR RESPECTIVE EXPIRATION DATES AT THE TIME OF THE ORIGINAL SURGERY AND THE PREVIOUS REVISION ON (B)(6) 2013. THERE WERE NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS COMPLAINT THAT CONTRIBUTED TO THE INFECTION. A REVIEW OF THE IMPLANT DEVICE HISTORY RECORDS, PRODUCT COMPLAINT REPORT DATABASE, AND STERILIZATION RECORDS SHOW THAT THE REPORTED COMPONENTS USED IN THE ORIGINAL SURGERY MET STERILIZATION, DESIGN, AND MANUFACTURING REQUIREMENTS. NO INFORMATION WAS SUBMITTED WITH THE COMPLAINT REGARDING PRE-EXISTING CONDITIONS OF THE PATIENT OR ANY ACTIVITIES THE PATIENT WAS INVOLVED IN THAT MAY HAVE CONTRIBUTED TO THE INFECTION OR INHIBITED THE PATIENT'S IMMUNE SYSTEM. THE SURGERY OCCURRED 20 DAYS APART SO IT IS POSSIBLE THE PATIENT CONTRACTED THE INFECTION WHILE STILL IN THE HOSPITAL (NOSOCOMIAL). IT IS ALSO POSSIBLE THE PATIENT DID NOT ADHERE TO POST SURGICAL INSTRUCTIONS. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO INFECTION THAT ARE OUTSIDE OF THE CONTROL OF DJO SURGICAL. THE DATA REVIEWED IN THIS REPORT SUPPORTS THAT IF THE PATIENT WAS SUFFERING FROM AN INFECTION IT WAS NOT THE RESULT OF A PRODUCT OR MANUFACTURING PROCESS DEFECT.

    Description of Event or Problem · 1

    SECOND REVISION SURGERY - THE PATIENT PRESENTED WITH A DEEP INFECTION OF THE SHOULDER. THE SURGEON REMOVED ALL IMPLANTS AND REPLACED THEM WITH AN ANTIBIOTIC SPACER. THE PREVIOUS REVISION IS REFERENCED IN (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102785 RSP SHOULDER HYDROXYAPATITE-COATED GLENOID BASEPLATE KWS ENCORE MEDICAL, L.P. 866C1429

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention 506-00-008, LOT 814C1112| 508-00-032. LOT 855C1178| 506-03-118, LOT 832C1072| 508-00-000, LOT 848C1289| 508-32-101, LOT 862C1189| 506-03-134, LOT 836C1025