BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE CNV GLEN BASE NON HA

    MDR report key: 8381556 · Received March 1, 2019

    Report

    Report Number
    0001825034-2019-00913
    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
    KWS
    PMA / PMN Number
    K130390
    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. PRODUCT CODE: PHX. 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 # 115310, LOT # 990660, COMP RVRS SHLDR GLNSP STD 36MM. PART # XL-115363, LOT # 499200, ARCOM XL 44-36 STD HMRL BRNG. 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 DRL. 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: 0001825034-2019-00915. 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
    176698 COMPREHENSIVE CNV GLEN BASE NON HA PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 184150

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R 118001,VERSA-DIAL/COMP TISTD TAPER, 120880