BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE STANDARD TAPER ADAPTOR

    MDR report key: 8657723 · Received May 31, 2019

    Report

    Report Number
    0001825034-2019-02385
    Event Type
    Injury
    Date Received
    May 31, 2019
    Date of Event
    July 3, 2018
    Report Date
    September 11, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    PMA / PMN Number
    K060716
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CORRECTION: THE IMPLANT DATE IS (B)(6) 2017 AND NOT (B)(6) 2017 WHICH WAS PREVIOUSLY REPORTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 02386, 0001825034 - 2019 - 02388, 0001825034 - 2019 - 02389, 0001825034 - 2019 - 04047.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE CORRECT NOTIFICATION DATE FOR 0001825034-2019-02385 IS MAY 1, 2019 NOT JULY 11, 2018.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT PATIENT HAD INITIAL COMPREHENSIVE SHOULDER ARTHROPLASTY. SUBSEQUENTLY, PATIENT SUFFERED SHOULDER PAIN, INSTABILITY, TENDERNESS, DECREASE IN ADLS AND IMPINGEMENT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). UDI: (B)(4). CONCOMITANT MEDICAL PRODUCTS: 115732, COMPREHENSIVE NANO HUMERAL COMPONENT PPS, 410710; 113952, MODULAR HYBRID GLENOID BASE , 932710; PT-113950, MODULAR HYBRID GLENOID POST¿REGENEREX, 573810; 113032, VERSA-DIAL HUMERAL HEAD, 842820 . FOREIGN COUNTRY: (B)(6). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. AS PER THE OPERATIVE RECORDS AND X-RAYS PROVIDED, THE ROTATOR CUFF WAS NORMAL. HUMERAL HEAD HAD NORMAL CONTOUR AND THE GLENOID WAS NORMAL. THERE WERE NO COMPLICATIONS, DEVIATIONS FROM SURGICAL TECHNIQUE, OR DELAYS IN THE PROCEDURE. AS PER THE X-RAY REVIEW OF 6-MONTHS POST INITIAL SURGERY, NO GLENOID AND HUMERAL RADIOLUCENCY, SUBSIDENCE, OSTEOLYSIS, MIGRATION, INTEGRITY IS INTACT AND NO BONE FRACTURE. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 - 02386, 0001825034 - 2019 - 02388, 0001825034 - 2019 - 02389. THIS PRODUCT WAS PREVIOUSLY REPORTED UNDER MFR 0001825034 - 2018 - 10765.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT PATIENT HAD INITIAL COMPREHENSIVE SHOULDER ARTHROPLASTY. SUBSEQUENTLY, SIX (6) MONTHS POST INITIAL SURGERY PATIENT SUFFERED FROM PATIENT SUFFERED SHOULDER PAIN, INSTABILITY, TENDERNESS, DECREASE IN ADLS AND IMPINGEMENT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451972 COMPREHENSIVE STANDARD TAPER ADAPTOR PROSTHESIS, SHOULDER MBF ZIMMER BIOMET, INC. N/A 076840

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R