BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA-DIAL 42X18X46 HUM HEAD

    MDR report key: 18347265 · Received December 18, 2023

    Report

    Report Number
    0001825034-2023-02993
    Event Type
    Injury
    Date Received
    December 18, 2023
    Date of Event
    September 20, 2022
    Report Date
    December 18, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    UDI-DI
    00880304212206
    PMA / PMN Number
    K193038
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ITEM# 113651; LOT# 416660. ITEM# 118001; LOT# 558440. ITEM# 113952; LOT# 216270. ITEM# PT-113950; LOT# 929740. G2: FOREIGN - EVENT OCCURRED IN AUSTRALIA. ROTATOR CUFF INJURIES OCCUR MOST OFTEN IN PEOPLE WHO REPEATEDLY PERFORM OVERHEAD MOTIONS OR EXPERIENCE ANY SORT OF TRAUMA TO THE SHOULDER. DEGENERATIVE TEARS CAN ALSO OCCUR BECAUSE OF GRADUAL WEARING DOWN OF THE TENDON. THIS DEGENERATION NATURALLY OCCURS AS WE AGE. FACTORS THAT LEAD TO DEGENERATIVE TEARS INCLUDE REPETITIVE STRESS, LACK OF BLOOD SUPPLY, BONE SPURS, AND INCREASED AGE. COMMON SYMPTOMS OF A ROTATOR CUFF TEAR INCLUDE PAIN AT REST OR WITH ACTIVITY, WEAKNESS, AND CREPITUS. TYPICALLY, AN ANATOMIC SHOULDER IS PERFORMED WHEN THE ROTATOR CUFF IS STABLE AND INTACT, AND A REVERSE SHOULDER IS PERFORMED FOR AN INSUFFICIENT ROTATOR CUFF. THE ROOT CAUSE WAS DETERMINED TO BE TRACED TO NON-DEVICE RELATED FACTORS. 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 LEFT SHOULDER ARTHROPLASTY APPROXIMATELY FIVE (5) YEARS AGO. SUBSEQUENTLY, THE PATIENT HAD A REVISION ON THREE (3) MONTHS AGO DUE TO A SUPRASPINATUS TEAR IN THE ROTATOR CUFF. NO OTHER PATIENT CONSEQUENCES HAVE BEEN REPORTED AS A RESULT OF THE EVENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77901 VERSA-DIAL 42X18X46 HUM HEAD PROSTHESIS, SHOULDER, SEMI-CONSTRAINED MBF ZIMMER BIOMET, INC. NI 404570 00880304212206

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Hospitalization| R SEE NARRATIVE IN H10.