BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAR HYBRID GLENOID POST¿REGENEREX

    MDR report key: 8079215 · Received November 16, 2018

    Report

    Report Number
    0001825034-2018-10768
    Event Type
    Injury
    Date Received
    November 16, 2018
    Date of Event
    July 3, 2018
    Report Date
    May 31, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K060694
    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

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. UPON REASSESSMENT OF THE REPORTED EVENT, THIS MEDWATCH WAS DETERMINED TO BE NOT REPORTABLE. THIS WILL BE REPORTED UNDER MFR 0001825034-2019-20388.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, THIS MEDWATCH WAS DETERMINED TO BE NOT REPORTABLE. THIS WILL BE REPORTED UNDER MFR 0001825034-2019-20388.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 115732,COMPREHENSIVE NANO HUMERAL COMPONENT PPS,410710, 118001,COMPREHENSIVE STANDARD TAPER ADAPTOR,076840, 113952,MODULAR HYBRID GLENOID BASE ,932710, 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 - 2018 - 10765, 0001825034 - 2018 - 10767, 0001825034 - 2018 - 10770.

    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
    918954 MODULAR HYBRID GLENOID POST¿REGENEREX PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 573810

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R