BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVS TRAY +5MM CO 44MM

    MDR report key: 8382184 · Received March 1, 2019

    Report

    Report Number
    0001825034-2019-00924
    Event Type
    Injury
    Date Received
    March 1, 2019
    Date of Event
    September 11, 2018
    Report Date
    June 24, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K113069
    Removal / Correction Number
    N/A
    Adverse Event
    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. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). TWO HUMERAL TRAYS WERE REPORTED WERE REPORTED IN CONJUNCTION WITH THIS EVENT. IT IS UNKNOWN WHICH DEVICE WAS USED IN THE 2ND REVISION SURGERY. THE INFORMATION FOR THE 2ND TRAY IS AS FOLLOWS: CATALOG NUMBER: 115370, CATALOG NUMBER:272100, EXPIRATION DATE: JUN 19, 2022, MANUFACTURE DATE: : JUN 19, 2017, (B)(4). CONCOMITANT MEDICAL PRODUCTS: PART # 113627, LOT # 292310, COMP PRIMARY STEM 7MM MINI, PART # 115310, LOT # 990660, COMP RVRS SHLDR GLNSP STD 36MM, PART # 110005273, LOT # 184150, COMP CNV GLEN BASE NON HA, PART # XL-115363, LOT # 588250 OR 145510, ARCOM XL 44-36 STD HMRL BRNG, PART # 115395, LOT # 650420, COMP RVS CNTRL 6.5X25MM ST/RST, PART # 180551, LOT # 969080, COMP LK SCR 3.5HEX 4.75X20 ST, PART # 180552, LOT # 715590, COMP LK SCR 3.5HEX 4.75X25 ST, 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, PART # 110005237, LOT # 509950, COMP CONV GLEN LINER E1, PART # 118001, LOT # 12088,0 VERSA-DIAL/COMP TI STD TAPER. 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 -00920, 0001825034 -2019 -00921, 0001825034 -2019 -00922, 0001825034 -2019 -00923, 0001825034 -2019 -00925, 0001825034 -2019 -00926. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT PATIENT IS SUFFERING FROM CHRONIC PAIN AND NON FUNCTIONING JOINT (9) NINE MONTHS POST REVISION SURGERY. PATIENT IS UNDERGOING SEEKING CARE UNDER A PAIN MANAGEMENT SPECIALIST. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174455 COMP RVS TRAY +5MM CO 44MM PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 822460

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention| S