BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA-DIAL SHOULDER SYSTEM MODULAR HEAD W/VARIABLE OFFSET 42MM X 18MM X 46MM

    MDR report key: 5957130 · Received September 16, 2016

    Report

    Report Number
    0001825034-2016-03656
    Event Type
    Injury
    Date Received
    September 16, 2016
    Date of Event
    March 12, 2015
    Report Date
    May 25, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBF
    PMA / PMN Number
    PK060716
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 13 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN."

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT: COMPREHENSIVE PRIMARY STEM 11 MM MINI, CATALOG#: 113631, LOT#: 503990; VERSA-DIAL/COMPREHENSIVE TI STANDARD TAPER, CATALOG#: 118001, LOT#: 115820; MD HYBRID GLENOID BASE 4 MM, CATALOG#: 113954, LOT#: 696930; PT HYBRID GLENOID POST REGENEREX, CATALOG#: PT-113950, LOT#: 052420. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. X-RAY REVIEW INDICATES THAT PROGRESSIVE GLENOID COMPONENT RADIOLUCENCY IS DETECTED IN ZONES 1, 2, 3, AND 4 BETWEEN THE MONTH 3 AND MONTH 12 FOLLOW-UP VISITS. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-02414/ 0001825034-2017-02416/ 0001825034-2017-02417/ 0001825034-2017-02418/0001825034-2017-02419/0001825034-2017-02420/0001825034-2017-02421/0001825034-2017-02422/0001825034-2017-02423.

    Description of Event or Problem · 1

    PATIENT ENROLLED IN A CLINICAL STUDY REPORTED RIGHT SHOULDER PAIN AND PULLING SENSATION AROUND THE INCISION SITE APPROXIMATELY 1 YEAR POST-IMPLANTATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, PAIN, INSTABILITY, AND ACROMIOCLAVICULAR JOINT TENDERNESS WERE NOTED AT THREE MONTH POST-OPERATIVE FOLLOW-UP. AT ONE YEAR POST-OPERATIVE FOLLOW-UP, BICEPS TENDON TENDERNESS, IMPINGEMENT, UNUSUAL SHOULDER PAIN AND PULLING SENSATION AROUND THE INCISION SITE, AND A "PUCKERING IN" DEFORMITY OF THE RIGHT MIDDLE OF THE SHOULDER WERE REPORTED. INSTABILITY HAD RESOLVED. NO REVISION PROCEDURE HAS BEEN INDICATED AT THIS TIME, AS THE ISSUE REMAINS TOLERATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, PAIN AND ACROMIOCLAVICULAR JOINT TENDERNESS WERE NOTED AT THREE MONTH POST-OPERATIVE FOLLOW-UP. AT ONE YEAR POST-OPERATIVE FOLLOW-UP, BICEPS TENDON TENDERNESS, IMPINGEMENT, UNUSUAL SHOULDER PAIN AND PULLING SENSATION AROUND THE INCISION SITE, AND A "PUCKERING IN" DEFORMITY OF THE RIGHT MIDDLE OF THE SHOULDER WERE REPORTED. NO REVISION PROCEDURE HAS BEEN INDICATED AT THIS TIME, AS THE ISSUE REMAINS TOLERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609046 VERSA-DIAL SHOULDER SYSTEM MODULAR HEAD W/VARIABLE OFFSET 42MM X 18MM X 46MM PROSTHESIS, SHOULDER MBF BIOMET ORTHOPEDICS N/A 620590

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other