BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP LOCKING SCREW 4.75X20MM

    MDR report key: 12010471 · Received June 16, 2021

    Report

    Report Number
    0001825034-2021-01816
    Event Type
    Injury
    Date Received
    June 16, 2021
    Date of Event
    May 10, 2021
    Report Date
    September 9, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSD
    PMA / PMN Number
    K113069
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS THE 5 YEAR POSTOPERATIVE IMAGES DEMONSTRATE NORMAL ALIGNMENT. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). DOB (B)(6). CONCOMITANT MEDICAL PRODUCTS: CATALOG #: 115734, COMPR NANO HMRL PPS 34MM, LOT # 089510; CATALOG #: 115340, COMP RVS HMRL TI TRAY 44MM, LOT # 184140; CATALOG #: XL-115363, ARCOM XL 44-36 STD HMRL BRNG RING, LOT # 203790; CATALOG #: 115310, COMP RVRS SHLDR GLNSP STD 36MM, LOT # 988200; CATALOG #: 115330, COMP RVRS SHDR GLEN BSPLT +HA, LOT # 577290; CATALOG #: 118001, VERSA-DIAL/COMP TI STD TAPER PR ADAPTOR, LOT # 780520; CATALOG #: 115382, COMP RVS CNTRL SCR, LOT # 762950; CATALOG #: 180500, COMP LOCKING SCREW, LOT # 007880 QTY. 2; CATALOG #: 180501, COMP LOCKING SCREW 4.75X20MM, LOT # UNKNOWN QTY. 2. REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS ITS LOCATION IS UNKNOWN. 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: 0001825034-2021-01731, 0001825034-2021-01808, 0001825034-2021-01809, 0001825034-2021-01810, 0001825034-2021-01811, 0001825034-2021-01812, 0001825034-2021-01813, 0001825034-2021-01814, 0001825034-2021-01815, 0001825034-2021-01817. PRODUCT LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL RIGHT REVERSE SHOULDER APPROXIMATELY 6 YEARS AGO. THE PATIENT UNDERWENT AN ACJ EXCISION SURGERY ABOUT 6 MONTHS LATER AND ANY ISSUES WERE NOTED AS RESOLVED. THE PATIENT IS NOW EXPERIENCING UNUSUAL SHOULDER PAIN WITH A SEVERE PAIN RATING, AND SANE SCORE DECLINE TO 30/100. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907243 COMP LOCKING SCREW 4.75X20MM PROSTHESIS, SHOULDER HSD ZIMMER BIOMET, INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other