BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PT HYBRID GLENOID POST REGENEREX POROUS TITANIUM CONSTRUCT

    MDR report key: 6440516 · Received March 28, 2017

    Report

    Report Number
    0001825034-2017-01395
    Event Type
    Injury
    Date Received
    March 28, 2017
    Report Date
    June 4, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PK060694
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO DEVICE OR PHOTOS WERE RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THIS UNIT, WITH NO DEVIATIONS OR ANOMALIES RELATED TO THE REPORTED EVENT BEING IDENTIFIED. THIS DEVICE IS USED FOR TREATMENT. A DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1825034-2016-03696 / 03694 / 03695, AND 0001825034-2017-01393 / 01394 / 01403.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. IN ADDITION TO THE INVESTIGATION PREVIOUSLY REPORTED, X-RAYS WERE RECEIVED AND REVIEWED FOR THIS PATIENT. THIS REVIEW IDENTIFIED RADIOLUCENCY AROUND THE GLENOID COMPONENTS. THE ROOT CAUSE REMAINS UNDETERMINED AT THIS TIME. CONCOMITANT DEVICES - VERSA-DIAL HUMERAL HEAD CATALOG #: 113053 LOT #: 355550, VERSA-DIAL COMPREHENSIVE STANDARD ADAPTOR CATALOG #: 118001 LOT #: 800650, COMPREHENSIVE NANO HUMERAL COMPONENT CATALOG #: US-115740 LOT #: 752510, HYBRID 4MM GLENOID BASE CATALOG #: 113956 LOT #: 904160. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN, INSTABILITY, MODERATE SUPRASPINATUS/GREATER TUBEROSITY TENDERNESS, MILD ACROMIOCLAVICULAR JOINT TENDERNESS, MILD BICEPS TENDON TENDERNESS, IMPINGEMENT, AND SUBACROMIAL CREPITUS NOTED AT SIX WEEKS POST-OPERATIVE FOLLOW-UP. CONTINUED PAIN, INSTABILITY, MILD BICEPS TENDON TENDERNESS, AND SUBACROMIAL CREPITUS NOTED AT THREE MONTH POST-OPERATIVE FOLLOW-UP. SUBSEQUENTLY, PAIN, INSTABILITY, MILD ACROMIOCLAVICULAR JOINT TENDERNESS WERE NOTED TO PERSIST INTO ONE YEAR POST-OPERATIVE FOLLOW-UP. NO REVISION HAS BEEN REPORTED TO DATE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222875 PT HYBRID GLENOID POST REGENEREX POROUS TITANIUM CONSTRUCT PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A 558340

    Patients

    Seq Age Sex Outcome Treatment
    1 Other