BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK ZIMMER TM REVERSE SHOULDER

    MDR report key: 4223378 · Received October 29, 2014

    Report

    Report Number
    1822565-2014-01469
    Event Type
    Injury
    Date Received
    October 29, 2014
    Report Date
    September 30, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED VIA PUBLISHED LITERATURE. EVALUATION SUMMARY: THE TM REVERSE SURGICAL TECHNIQUE STATES THAT "THE DRILL GUIDE SHOULD BE PLACED SO THAT THE OUTER RIM ALIGNS WITH THE INFERIOR RIM OF THE GLENOID AND IS CENTERED IN THE ANTERIOR/POSTERIOR DIRECTION. THIS WILL PLACE THE GLENOSPHERE AT THE EDGE OF THE INFERIOR GLENOID BONE." IT ALSO STATES THAT "NOTE: GUIDE PIN PLACEMENT IS CRITICAL AS IT DETERMINES BASED PLATE/GLENOSPHERE POSITION ON THE FACE OF THE GLENOID AND ORIENTATION IN THE SAGITTAL PLANE. THE DRILL GUIDE SHOULD BE CENTERED ANTERIORLY/POSTERIORLY, AND ALIGN TO THE INFERIOR BORDER OF THE GLENOID. AVOID PLACING THE GUIDE PIN WIT THE SUPERIOR TILT, AS THIS MAY RESULT IN A SUPERIORLY-TILTED BASE PLATE/GLENOSPHERE AND INCREASE THE RISK OF SCAPULAR NOTCHING." DUE TO THE LACK OF OPERATIVE NOTES AND X-RAYS IT IS UNK COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFO HOWEVER NO INFO HAS BEEN RECEIVED TO DATE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS WERE UNAVAILABLE. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFO, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THE PT IS EXPERIENCING GRADE 1 SCAPULAR NOTCHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692159 UNK ZIMMER TM REVERSE SHOULDER SHOULDER PROSTHESIS HSD ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other