BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPR NANO HMRL PPS 34MM

    MDR report key: 19498217 · Received June 10, 2024

    Report

    Report Number
    0001825034-2024-01523
    Event Type
    Injury
    Date Received
    June 10, 2024
    Date of Event
    April 7, 2016
    Report Date
    October 29, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A2 - 1932 D10 - MEDICAL PRODUCT: CATALOG #: 115340, COMP RVS HMRL TI TRAY 44MM, LOT # 994290 CATALOG #: XL-115363, ARCOM XL 44-36 STD HMRL BRNG, LOT # 172680 CATALOG #: 115310, COMP RVRS SHLDR GLNSP STD 36MM, LOT # 477120 CATALOG #: 010000589, COMP RVRS 25MM BSPLT HA+ADPTR, LOT # 096750 CATALOG #: 180502, COMP LOCKING SCREW 4.75X25MM CREW 25MM, LOT # UNKNOWN CATALOG #: 180500, COMP LOCKING SCREW 4.75X15MM CREW 15MM, LOT # UNKNOWN CATALOG #: 115382, COMP RVS CNTRL SCR 6.5X30MM ST 30MM, LOT # UNKNOWN G2: UNITED KINGDOM THIS PRODUCT WAS MANUFACTURED BY ZIMMER BIOMET AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. ANYMORE. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN WARSAW, INDIANA MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K182516. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). PROPOSED ANNEX G CODE: MECHANICAL (G04) STEM. UPDATED: B4, B5, D2, D4 (EXP DATE), G3, H1, H2, H3, H4, H6, H11. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. MEDICAL RECORDS/RADIOGRAPHS IDENTIFIED THE FOLLOWING: THERE IS A REVERSE-TYPE LEFT SHOULDER ARTHROPLASTY. THERE IS ABNORMAL ALIGNMENT OF THE GLENOSPHERE AND GLENOID BASEPLATE REFLECTING IMPLANT DISASSOCIATION. THERE IS NO FRACTURE OR EVIDENCE OF IMPLANT LOOSENING. IMPLANT FIT IS MAINTAINED. THERE IS MALALIGNMENT OF THE GLENOSPHERE AND BASEPLATE AS NOTED DUE TO DISASSOCIATION. BONE QUALITY IS OSTEOPENIC. PATIENT REPORTS PAIN ANTERIOR-SUPERIOR AND ANTERIOR-CENTRAL, TAKING PAIN MEDICATION. DIFFICULTIES WITH ADL¿S. ROM FORWARD FLEXION 61-90, LATERAL ELEVATION 61-90. IT WAS REPORTED THAT THE PATIENT RECEIVED A SUBSCAPULARIS NERVE BLOCK FOR PAIN. 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 REPORTED THAT PATIENT UNDERWENT AN INITIAL LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY PERFORMED APPROXIMATELY 9 YEARS AGO. SUBSEQUENTLY, ABOUT A YEAR LATER THE PATIENT REPORTED PAIN REQUIRING PAIN MEDICATION AND DIFFICULTIES WITH ACTIVITIES OF DAILY LIVING. IT WAS REPORTED A FEW WEEKS AGO THAT THE PATIENT RECEIVED A SUBSCAPULARIS NERVE BLOCK FOR PAIN. NO FURTHER DETAILS OR OUTCOMES PROVIDED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666216 COMPR NANO HMRL PPS 34MM PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 758530

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Other SEE H10.