BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS 25MM BSPLT HA+ADPTR

    MDR report key: 9307716 · Received November 11, 2019

    Report

    Report Number
    0001825034-2019-05038
    Event Type
    Injury
    Date Received
    November 11, 2019
    Date of Event
    September 27, 2019
    Report Date
    April 30, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00880304462489
    PMA / PMN Number
    K120121
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). UPDATED: B4, B5, D1, D4 (ITEM, LOT, EXP DATE, UDI), D6, G4, G5, H1, H2, H4, AND H10 D11 - MEDICAL PRODUCT: CATALOG #: 115370, COMP RVS TRAY CO 44MM, LOT # 471960. CATALOG #: XL-115363, ARCOM XL 44-36 STD HMRL BRNG, LOT # 270080. CATALOG #: 115310, COMP RVRS SHLDR GLNSP STD 36MM, LOT # 87550. CATALOG #: 180559, COMP NLK SCR 3.5HEX 4.75X25 ST, LOT # 135360. CATALOG #: 180551, COMP LK SCR 3.5HEX 4.75X20 ST, LOT # 352670. CATALOG #: 180552, COMP LK SCR 3.5HEX 4.75X25 ST, LOT # 339050. CATALOG #: 180550, COMP LK SCR 3.5HEX 4.75X15 ST, LOT # 869170. 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 · 0

    (B)(4). REPORTED EVENT WAS CONSIDERED CONFIRMED AS THE X-RAYS SHOW THERE IS LUCENCY ALONG THE GLENOID IMPLANT FIXATION SCREWS REFLECTING OSTEOLYSIS AND LOOSENING OF THE GLENOSPHERE. THE BASEPLATE COMPONENT WAS LOOSE AS WELL WHILE THE HUMERAL IS NOT. BONE QUALITY IS NOTED TO BE MILDLY OSTEOPENIC. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE 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

    IT WAS FURTHER REPORTED THAT THE PATIENT HAD AN INITIAL LEFT TOTAL SHOULDER ARTHROPLASTY APPROXIMATELY TWO (2) YEARS AGO. THE PATIENT WAS REVISED ABOUT A YEAR AGO DUE TO SUBSCAPULARIS FAILURE (COVERED UNDER A DIFFERENT COMPLAINT). THEN A MONTH LATER THE PATIENT WAS REVISED DUE TO A LOOSE BASEPLATE. THEN AGAIN ABOUT FOUR (4) MONTHS LATER FOR THE SECOND PART OF THE TWO STAGE REVISION OF THE LEFT SHOULDER.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG #: PT-113950, PT HYBRID GLEN POST REGENEREX, LOT # 724320, CATALOG #: 406669, STN PN THD TIP .125X2.5IN 2PK, LOT # 745160, CATALOG #: 113633, COMP PRIMARY STEM 13MM MINI, LOT # 180300, CATALOG #: 118001, VERSA-DIAL/COMP TI STD TAPER, LOT # 497590, CATALOG #: 113046, VERSA-DIAL 46X24X47 HUM HEAD, LOT # 753240. THE CUSTOMER HAS NOT INDICATED WHETHER THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION OR NOT. ONCE THIS INFORMATION IS OBTAINED A FOLLOW-UP MDR WILL BE SUBMITTED. 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. UNKNOWN IF PRODUCT WILL BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED AN INITIAL LEFT SHOULDER ARTHROPLASTY APPROXIMATELY A YEAR AGO. SUBSEQUENTLY A REVISION OCCURRED ABOUT 2 MONTHS AGO DUE TO A LOOSENING BASEPLATE AND BONE EROSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1098823 COMP RVRS 25MM BSPLT HA+ADPTR PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 605420 00880304462489

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R