BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA-DIAL/COMP TI STD TAPER

    MDR report key: 8381617 · Received March 1, 2019

    Report

    Report Number
    0001825034-2019-00915
    Event Type
    Injury
    Date Received
    March 1, 2019
    Date of Event
    July 3, 2017
    Report Date
    July 23, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    PMA / PMN Number
    K060716
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. UDI # (B)(4). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. REVIEW OF MEDICAL RECORDS IDENTIFIED THAT PATIENT WAS REVISED TO A BIOMET REVERSE SHOULDER REPLACEMENT DUE TO CHRONIC PAIN, WHICH CONTINUED POST REVISION RESULTING IN MODERATE TO SEVERE PAIN, LIMITED ROM, POPPING, AND DYSFUNCTION WITH THE LEFT SHOULDER. THERE WAS EXTENSIVE SCAR TISSUE ALONG WITH PERIPROSTHETIC FRACTURE OF THE PROXIMAL HUMERUS. X-RAY REVIEW IDENTIFIED THAT THERE IS OSTEOPENIA. LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY WITH POSSIBLE FRACTURE ALONG THE LATERAL CORTEX OF THE PROXIMAL HUMERAL DIAPHYSIS. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES DURING MANUFACTURING. ROOT CAUSE COULD NOT BE DETERMINED. 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: PART # 113627 LOT # 292310 COMP PRIMARY STEM 7MM MINI, PART # 110005237 LOT # 509950 COMP CONV GLEN LINER E1, PART # 115395 LOT # 650420 COMP RVS CNTRL 6.5X25MM ST/RST, PART # 180551 LOT # 969080 COMP LK SCR 3.5HEX 4.75X20 ST, PART # 115370 LOT # 973000 COMP RVS TRAY CO 44MM, PART # 118001 LOT # 120880 VERSA-DIAL/COMP TI STD TAPER, PART # 180552 LOT # 715590 COMP LK SCR 3.5HEX 4.75X25 ST, PART # 110005273 LOT # 184150 COMP CNV GLEN BASE NON HA, PART # 405883 LOT # 538650 COMP RVS 3.2MM DR,L PART # 405800 LOT # 905620 COMP. REV SHLDR 9 IN STEINMANN, PART # 405889 LOT # 538820 COMP RVS 2.7MM DIA DRL. 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 - 2019 - 00913. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT PATIENT WAS REVISED DUE TO DISASSOCIATION OF THE GLENOID COMPONENT CAUSING PAIN AND LIMITATIONS IN ACTIVITIES OF DAILY LIVING. SURGEON STATED EXTENSIVE SCAR TISSUE ALONG WITH PERIPROSTHETIC FRACTURE OF THE PROXIMAL HUMERUS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174792 VERSA-DIAL/COMP TI STD TAPER PROSTHESIS, SHOULDER MBF ZIMMER BIOMET, INC. N/A 120880

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R 110005273,COMP CNV GLEN BASE,184150