BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CR PROLONG 36MM BRNG STD

    MDR report key: 14552947 · Received May 31, 2022

    Report

    Report Number
    0001822565-2022-01645
    Event Type
    Injury
    Date Received
    May 31, 2022
    Date of Event
    September 3, 2019
    Report Date
    May 31, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00887868231490
    PMA / PMN Number
    K181611
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MEDICAL PRODUCTS: ITEM#: 115310, COMP RVRS SHLDR GLNSP STD 36MM; LOT#: 555040; ITEM#: 113628, COMP PRIMARY STEM 8MM MINI; LOT#: 092560. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DEVICES ARE USED FOR TREATMENT. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: A REVERSE-TYPE LEFT SHOULDER ARTHROPLASTY IS PRESENT. THE GLENOID IMPLANT APPEARS UNREMARKABLE. THERE IS SUBLUXATION OF THE HUMERAL IMPLANT WITH WIDENING OF THE PROSTHETIC GLENOHUMERAL SPACE SEEN ON THE AP VIEW. THERE IS ALSO A MILDLY DISPLACED FRACTURE OF THE PROXIMAL HUMERUS OF UNCERTAIN ACUITY WITH PROXIMAL HUMERAL CERCLAGE WIRE FIXATION. BONE QUALITY IS OSTEOPENIC. A DEFINITIVE ROOT CAUSE CANNOT 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 THE PATIENT UNDERWENT A REVISION SURGERY DUE TO DUE TO THE IMPLANT SUBLUXATION AND A BONE FRACTURE. THE PATIENT HAS BEEN REVISED ONE PREVIOUS TIME DUE TO BONE FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1724113 CR PROLONG 36MM BRNG STD SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES KWS ZIMMER BIOMET, INC. 110031418 64299880 00887868231490

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Hospitalization| R