BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVS TRAY CO 44MM

    MDR report key: 12232337 · Received July 27, 2021

    Report

    Report Number
    0001825034-2021-02198
    Event Type
    Injury
    Date Received
    July 27, 2021
    Date of Event
    February 27, 2020
    Report Date
    October 4, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00880304543201
    PMA / PMN Number
    K113069
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS AND RADIOGRAPHS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. RADIOGRAPHS IDENTIFIED THE FOLLOWING: VERY MINIMAL SCAPULAR NOTCHING NOTED ADJACENT TO THE THE INFEROMEDIAL BASE OF THE INFERIOR PORTION OF THE GLENOID BASE PLATE, DEMONSTRATED BY MINIMAL AMOUNT OF CORTICAL EROSION. THE GLENOSPHERE AND GLENOID BASE PLATE ALONG WITH THE ANCHORING SCREWS APPEAR INTACT. THE HUMERAL COMPONENT OF THE HARDWARE APPEARS UNREMARKABLE. NO DETECTED FRACTURE OR DISLOCATION. MEDICAL RECORDS IDENTIFIED THE FOLLOWING: INITIAL SURGERY NOTED NO COMPLICATIONS. FOLLOW UP NOTED MODERATE PAIN AND INSTABILITY, NO X-RAY FINDINGS. FURTHER FOLLOW UP NOTED SEVERE PAIN AND INSTABILITY, X-RAYS WERE REFUSED. THERE WAS BRUISING AND STIFFNESS OVER LEFT BICEPS TENDON, PAIN AND DECREASED ROM. CT SCAN ORDERED TO FURTHER EVALUATION, MRI ORDERED FOR FURTHER EVALUATION, LEFT SHOULDER ARTHROSCOPIC DEBRIDEMENT PERFORMED. FOLLOW UP NOTED SEVERE PAIN AND INSTABILITY. FURTHER FOLLOW UP NOTED EXTREME PAIN, INSTABILITY, UNABLE TO DO USUAL ACTIVITIES (ROM NOT MEASURABLE/UNABLE). IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT 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). PRODUCT CODE: PHX. CONCOMITANT PRODUCTS: REF 113626 LOT 646940 HUMERAL STEM; REF XL115364 LOT 090740 HUMERAL BEARING; REF 115310 LOT 708330 GLENOSPHERE; REF 110032410 LOT 64265378 GLENOID BASEPLATE; REF 115396 LOT 851690 CENTRAL SCREW; REF 180551 LOT 795380 SCREW; REF 180552 LOT 252690 SCREW; REF 180550 LOT 204230 SCREW; REF 180550 LOT 796740 SCREW. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE PRODUCT REMAINS IMPLANTED. 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 - 02199, 0001825034 - 2021 - 02200.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY PERFORMED. THE PATIENT HAS HAD AN ARTHROSCOPIC DEBRIDEMENT DUE TO PAIN, STIFFNESS, AND DECREASED RANGE OF MOTION. AFTER THE SURGERY, THE PATIENT CONTINUED TO HAVE SEVERE PAIN, INSTABILITY, AND WAS UNABLE TO PERFORM USUAL ACTIVITIES. SMALL NOTCHING WAS NOTED AT THE MOST RECENT FOLLOW UP. NO EXCHANGE OF PRODUCT OR FURTHER INTERVENTION HAS TAKEN PLACE TO DATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1132171 COMP RVS TRAY CO 44MM PROSTHESIS, SHOULDER PHX ZIMMER BIOMET, INC. N/A 632000 00880304543201

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O