BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVERSE/REVERSE SCREW SYSTEM, 4.5-48

    MDR report key: 4824205 · Received June 4, 2015

    Report

    Report Number
    9613350-2015-00644
    Event Type
    Other
    Date Received
    June 4, 2015
    Date of Event
    May 1, 2015
    Report Date
    May 21, 2015
    Manufacturer
    ZIMMER TRABECULAR METAL REVERSE SHOULDER SYST
    Product Code
    HSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS WERE MADE AVAILABLE. THE PRODUCTS RELATED TO THIS COMPLAINT WERE NOT RETURNED FOR INVESTIGATION. PAIN CANNOT BE RELATED TO A SINGLE SPECIFIC FAILURE MODE WITHIN THE RISK MANAGEMENT FILE. BASED ON THE GIVEN INFORMATION, A FINAL ASSESSMENT IS THEREFORE NOT POSSIBLE. HOWEVER, ALL POTENTIAL FAILURE MODES AND CAUSES ARE COVERED IN THE CORRESPONDING DFMEAS. SHOULD ANY ADDITIONAL INFORMATION THAT CHANGES THE ASSESSMENT BECOME AVAILABLE TO US, WE WILL RE-EVALUATE THE CASE. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, THE COMPLAINT COULD NOT BE CONFIRMED AS THE ALLEGED FAILURE COULD NOT BE IDENTIFIED OR REPRODUCED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4). NOTE: THIS IS A SPLIT CASE WITH ZIMMER INC., (B)(4) REFERENCE NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES AS THE PT HAS NOT BEEN REVISED. 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 INFO PROVIDED. SHOULD ADD'L INFO BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THREE X-RAYS DATED (B)(6) 2015 ARE AVAILABLE FOR INVESTIGATION. THE X-RAYS SHOW THE CORRECT POSITIONING OF THE IMPLANT AND A SUBACROMIAL CALCIFICATION OF THE OPERATIVE SHOULDER. TWO RADIOLUCENT ZONES ARE VISIBLE IN THE AREA OF THE GREATER TUBERCLE AND OF THE SURGICAL NECK OF THE HEMERUS. NO OTHER EVIDENT OBSERVATIONS CAN BE DONE. THE SURGICAL REPORT OF IMPLANTATION AND THREE FOLLOW-UP REPORTS ARE AVAILABLE. THE SURGICAL REPORT DESCRIBES THE OPERATIVE PROCEDURE ON (B)(6) 2016. THE REPORTS OF (B)(6) 2013 DO NOT REPORT ANY PROBLEM OF THE PATIENT. THE REPORT OF (B)(6) 2015 STATES THAT THE PATIENT HAS MILD DISCOMFORT AND CRACKING IN HER SHOULDER AND CALCIFICATION IN THE SUBACROMIAL SPACC. NO EVIDENCE OF LOOSENING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS IMPLANTED AN INVERSE/REVERSE SCREW SYSTEM, 4.5-48 ON THE LEFT SHOULDER ON (B)(6) 2013. IT WAS REPORTED THAT THE PT EXPERIENCED PAIN IN THE LEFT SHOULDER ON (B)(6) 2015. THE PT HAS NOT BEEN REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363551 INVERSE/REVERSE SCREW SYSTEM, 4.5-48 ZIMMER TRABECULAR METAL REVERSE SHOULDER HSD ZIMMER TRABECULAR METAL REVERSE SHOULDER SYST NA 2648143

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other