BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVERSE/REVERSE SCREW SYSTEM, 4.5-18

    MDR report key: 3962558 · Received July 14, 2014

    Report

    Report Number
    9613350-2014-03716
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 19, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH X-RAY PICTURES WERE RECEIVED FOR REVIEW, THE MANUFACTURER DID NOT RECEIVE THE DEVICES NOR SURGICAL REPORTS FOR REVIEW. THE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED, ONCE MORE SUBSTANTIAL INFORMATION IS RECEIVED OR THE DEVICES ARE RECEIVED AND INVESTIGATED, AND UPDATED REPORT WILL BE SUBMITTED. ZIMMER REF NUMBER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER SURGERY ON (B)(6) 2013 AND WAS IMPLANTED WITH ZIMMER (B)(4) PRODUCTS WHICH ARE: AS INVERSE/REVERSE HUMERAL CUP (STANDARD), AS INVERSE HUMERAL PE-INLAY 36-0, INVERSE/REVERSE SCREW SYSTEM, 4.5-30 AND ZIMMER (B)(4) PRODUCTS (STEM, TRABECULAR METAL BASE PLATE AND THE GLENOSPHERE). ON (B)(6) 2014, IT WAS MADE AWARE THAT THERE WAS A DISASSEMBLING BETWEEN THE TRABECULAR METAL BASE PLATE AND THE GLENOSPHERE. AN X-RAY PICTURE WAS PROVIDED TO CONFIRM THE MOVEMENT. ON (B)(6) 2014, THE PATIENT UNDERWENT REVISION SURGERY DUE TO DISASSEMBLING BETWEEN THE TRABECULAR METAL BASE PLATE AND THE GLENOSPHERE TO, AND REMOVED THE TWO SCREW SYSTEM (4.5-18 AND 4.5-30) AND BOTH WERE REPLACED WITH INVERSE/REVERSE SCREW SYSTEM 4.5-30. ALSO THE AS INVERSE/REVERSE HUMERAL PE-INLAY AND THE AS INVERSE/REVERSE HUMERAL CUP, WERE REPLACED. NB: THE (B)(4) PRODUCTS IS BEING REPORTED BY ZIMMER (B)(4) WITH REFERENCE NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409339 INVERSE/REVERSE SCREW SYSTEM, 4.5-18 INVERSE/REVERSE SCREW SYSTEM, 4.5-18 HWC ZIMMER GMBH 2494779

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R