BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYBRID GLENOID BASE 4 MM MEDIUM

    MDR report key: 6521613 · Received April 26, 2017

    Report

    Report Number
    0001825034-2017-02796
    Event Type
    Injury
    Date Received
    April 26, 2017
    Date of Event
    December 18, 2015
    Report Date
    July 7, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PK060694
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. THE OPERATIVE RECORD WAS REVIEWED. THE ROTATOR CUFF WAS NORMAL. THE NATIVE HUMERAL HEAD HAD DEFORMITY, PERIPHERAL OSTEOPHYTES AND SEGMENTAL HEAD EROSION. THE NATIVE GLENOID HAD POSTERIOR EROSION AND OSTEOPHYTES. THERE WERE NO SURGICAL COMPLICATIONS, DEVIATIONS FROM THE SURGICAL TECHNIQUE, OR DELAYS IN THE PROCEDURE. THE PATIENT HAD AN ATV ACCIDENT AFTER THE 3 MONTH VISIT AND THIS LIKELY CONTRIBUTED TO THE REPORTED EVENTS REPORTED AT 1 YEAR AND 2 YEARS POST OP. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT: PT HYBRID GLENOID POST GEGENEREX POROUS TI CONSTRUCT CAT#: PT-113950 LOT#: 868190, VERSA-DIAL SHOULDER SYSTEM MODULAR HEAD WITH VARIABLE OFFSET CAT#: 113053 LOT#: 466480, VERSA-DIAL SHOULDER SYSTEM COMPREHENSIVE ADAPTOR CAT#: 118001 LOT#: 530440, COMPREHENSIVE SHOULDER SYSTEM MINI STEM CAT#: 113632 LOT#: 760090. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-02796, 02797, 02799, 02800, 02801.

    Description of Event or Problem · 1

    IT IS REPORTED THAT PATIENT UNDERWENT INITIAL LEFT SHOULDER ARTHROPLASTY. PATIENT BEGAN REPORTING PAIN AT THE 6-WEEK FOLLOW-UP, WHICH RESOLVED BY THE 2-YEAR FOLLOW-UP. THREE MONTHS POST-IMPLANTATION, THE PATIENT ALSO REPORTED INSTABILITY AND IMPINGEMENT. ONE YEAR POST-IMPLANTATION, THE PATIENT REPORTED INSTABILITY, AND THE PATIENT'S RADIOGRAPHS REVEALED 1MM OF GLENOID RADIOLUCENCY. AT 2 YEARS POST-IMPLANTATION, THE PATIENT REPORTED MILD INSTABILITY. NO REVISION HAS BEEN REPORTED, AND OUTCOME OF TREATMENT IS TOLERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305752 HYBRID GLENOID BASE 4 MM MEDIUM PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A 917630

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other