BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYBRID GLENOID POROUS TITANIUM GLENOID POST

    MDR report key: 6228500 · Received January 6, 2017

    Report

    Report Number
    0001825034-2017-00065
    Event Type
    Injury
    Date Received
    January 6, 2017
    Date of Event
    August 1, 2016
    Report Date
    June 1, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PK060694
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MEDICAL PRODUCT: COMPREHENSIVE SHOULDER SYSTEM MINI HUMERAL STEM, CATALOG#: 113634, LOT#: 294510. COMPREHENSIVE SHOULDER SYSTEM STANDARD TAPER ADAPTOR, CATALOG#: 118001, LOT#: 429980. COMPREHENSIVE SHOULDER SYSTEM MODULAR HEAD VARIABLE OFFSET, CATALOG#: 113065, LOT#: 337270. HYBRID GLENOID BASE, CATALOG#: 113956, LOT#: 193480. COMPLAINT X-RAYS WERE EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. THE X-RAY REVIEWER STATED "LEFT TOTAL SHOULDER ARTHROPLASTY COMPONENTS REMAIN INTACT AND APPEAR GROSSLY UNREMARKABLE AT ONE YEAR. THE CAUSE OF THE REPORTED EVENTS IS NOT CLEARLY INDICATED ON X-RAYS. CLINICAL SYMPTOMS OF PAIN, INSTABILITY AND IMPINGEMENT MAY BE RELATED TO SOFT TISSUE FACTORS (EXAMPLE ROTATOR CUFF PATHOLOGY) NOT APPARENT ON X-RAYS." DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES 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

    PATIENT REPORTED PAIN, INSTABILITY, IMMOBILITY, TENDERNESS, AND IMPINGEMENT IN THE OPERATIVE LEFT SHOULDER POST OP. (B)(4). THIS REPORT IS NUMBER 5 OF 5 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2017-00058/ 00060/00062/ 00064).

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT PATIENT BEGAN EXPERIENCING PAIN, APPROXIMATELY 6 MONTHS POST-OPERATIVELY. AT 12 MONTHS POST-OPERATIVELY, PATIENT REPORTED PAIN, INSTABILITY, IMMOBILITY, IMPINGEMENT, AND TENDERNESS. NO REVISION HAS BEEN SCHEDULED. OUTCOME OF TREATMENT IS PENDING.

    Description of Event or Problem · 1

    PATIENT REPORTEDLY EXPERIENCED PAIN, INSTABILITY, AND TENDERNESS NOTED APPROXIMATELY SIX WEEKS POST-IMPLANTATION. UNUSUAL PAIN WAS ADDITIONALLY REPORTED WITH ONSET APPROXIMATELY SIX MONTHS POST-OPERATIVELY. CONTINUED PAIN, INSTABILITY, TENDERNESS, AND IMPINGEMENT WERE FURTHER NOTED APPROXIMATELY TWELVE MONTHS POST-IMPLANTATION. NO REVISION HAS BEEN REPORTED TO DATE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT PATIENT BEGAN EXPERIENCING PAIN APPROXIMATELY 6 MONTHS POST-OPERATIVELY. AT 12 MONTHS POST-OPERATIVELY, PATIENT REPORTED PAIN, INSTABILITY, IMMOBILITY, IMPINGEMENT, AND TENDERNESS. IT WAS FURTHER REPORTED AT TWO (2) YEAR FOLLOW-UP, THAT PATIENT IS STILL EXPERIENCING PAIN, TENDERNESS, SUBACROMIAL CREPITUS, AND LIMITED RANGE OF MOTION. THE ISSUES WERE NOTED TO BE TOLERATED, AND NO REVISION OR FURTHER TREATMENT HAS BEEN INDICATED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12060 HYBRID GLENOID POROUS TITANIUM GLENOID POST PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS NI 286100

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other