BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP LK SCR 3.5HEX 4.75X25 ST

    MDR report key: 9153467 · Received October 3, 2019

    Report

    Report Number
    0001825034-2019-04483
    Event Type
    Injury
    Date Received
    October 3, 2019
    Report Date
    October 31, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K132239
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: CATALOG #: 115310, COMP RVRS SHLDR GLNSP STD 36MM, LOT # 670930 ; CATALOG #: 180553, COMP LK SCR 3.5HEX 4.75X30 ST, LOT # 541780 ; CATALOG #: 180553, COMP LK SCR 3.5HEX 4.75X30 ST, LOT # 472190 ; CATALOG #: 180552, COMP LK SCR 3.5HEX 4.75X25 ST, LOT # 593030 ; CATALOG #: 115397, COMP RVS CNTRL 6.5X35MM ST/RST, LOT # 172790 ; CATALOG #: 180561, COMP NLK SCR 3.5HEX 4.75X35 ST, LOT # 251830 ; CATALOG #: UNKNOWN, UNKNOWN BASEPLATE, LOT # UNKNOWN ; CATALOG #: UNKNOWN, UNKNOWN STEM, LOT # UNKNOWN ; CATALOG #: UNKNOWN, UNKNOWN HUMERAL TRAY, LOT # UNKNOWN ; CATALOG #: UNKNOWN, UNKNOWN HUMERAL BEARING, LOT # UNKNOWN; CATALOG #: UNKNOWN, UNKNOWN TAPER ADAPTOR, LOT # UNKNOWN . 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-04389, 0001825034-2019-04480, 0001825034-2019-04482, 0001825034-2019-04483, 0001825034-2019-04484, 0001825034-2019-04485, 0001825034-2019-04487, 0001825034-2019-04488, 0001825034-2019-04490, 0001825034-2019-04491, 0001825034-2019-04492. UNKNOWN IF PRODUCT WILL BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT LEFT TOTAL REVERSE SHOULDER ARTHROPLASTY SUBSEQUENTLY, THAT PATIENT EXPERIENCED PAIN, LOSS OF RANGE OF MOTION AND LOOSENING OF THE COMPONENTS AND UNDERWENT A REVISION PROCEDURE ONE(1) YEAR ONE(1) MONTH FOURTEEN DAYS (14) MONTHS POST IMPLANTATION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    947548 COMP LK SCR 3.5HEX 4.75X25 ST PROSTHESIS SHOULDER KWS ZIMMER BIOMET, INC. N/A 593030

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R