BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMICAL SHOULDER REVERSE, SCREW SYSTEM, 4.5-30

    MDR report key: 6587165 · Received May 24, 2017

    Report

    Report Number
    0009613350-2017-00679
    Event Type
    Injury
    Date Received
    May 24, 2017
    Report Date
    October 13, 2017
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWT
    PMA / PMN Number
    PK052906
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS (DHR): THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. REVIEW OF EVENT DESCRIPTION: PATIENT WAS IMPLANTED WITH ANATOMICAL SHOULDER SCREWS ON (B)(6), 2015 AND EXPERIENCED PAIN AND LIMITED RANGE OF MOTION. IT IS REPORTED THAT X-RAYS (WHICH HAVE NOT BEEN SENT WITH THE COMPLAINT) SHOWS SOME SEPARATION. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS (STILL IMPLANTED). CONCLUSION SUMMARY: THE COMPLAINT DESCRIPTION IS RANGE OF MOTION ISSUES AND PAIN. IT CAN BE ASSUMED THAT THE ISSUE RANGE OF MOTION IS NOT RELATED TO ONE OF THE SCREWS IN THE COMPLAINT. THIS IS A SPLIT COMPLAINT WITH WARSAW ANATOMICAL SHOULDER DEVICES. THE SCREWS ARE ONLY ANCILLARY DEVICES AND NOT SPECIFICALLY RELATED TO THE ISSUE REPORTED. THE COMPLAINT INVESTIGATION FOR RANGE OF MOTION IS TREATED IN THE SPLIT CASE WITH ZIMMER INC., WARSAWREFERENCE NUMBER (B)(4). THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION AS THEY ARE STILL IMPLANTED. NO SURGICAL REPORT OR X-RAYS WERE PROVIDED FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. AS SOON AS ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. NOTE: THIS IS A SPLIT CASE WITH ZIMMER INC., (B)(4). (B)(4). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED AN ANATOMICAL SHOULDER REVERSE, SCREW SYSTEM, 4.5-30 ON THE LEFT SIDE ON (B)(6) 2015 AND IS CURRENTLY EXPERIENCING PAIN AND LIMITED RANGE OF MOTION. THE PATIENT IS BEING MONITORED. IT HAS BEEN REPORTED THAT X-RAYS (WHICH HAVE NOT BEEN SENT FOR REVIEW) SHOWS SOME SEPARATION. NOTE: THIS IS A SPLIT CASE WITH ZIMMER INC., (B)(4). (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370653 ANATOMICAL SHOULDER REVERSE, SCREW SYSTEM, 4.5-30 ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM KWT ZIMMER GMBH N/A 2798845

    Patients

    Seq Age Sex Outcome Treatment
    1 Other