BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PT HYBRID GLEN POST REGENEREX GENEREX

    MDR report key: 8850422 · Received August 1, 2019

    Report

    Report Number
    0001825034-2019-03256
    Event Type
    Injury
    Date Received
    August 1, 2019
    Date of Event
    May 15, 2019
    Report Date
    September 11, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWT
    PMA / PMN Number
    K060694
    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. REPORTED EVENT WAS CONFIRMED BY REVIEW OF RADIOGRAPHS AND MEDICAL RECORDS. REVIEW OF AVAILABLE MEDICAL RECORDS CONFIRMS THAT THE GLENOID SCREW WAS NOT WELL INTEGRATED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 115732 410710 COMPR NANO HMRL PPS 32MM, 118001 076840 VERSA-DIAL/COMP TI STD TAPER PR ADAPTOR, 113032 842820 VERSA-DIAL 42X18X46 HUM HEAD, 113952 932710 SM HYBRID GLENOID BASE 4MM. REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE HAS BEEN DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A CLINICAL STUDY THAT THE PATIENT HAD RIGHT SHOULDER ARTHROPLASTY AND WAS EXPERIENCING PAIN AND UNDERWENT AND OPEN BICEPS TENOTOMY APPROXIMATELY ONE(1) YEAR ONE (1) MONTH POST INITIAL SURGERY. SUBSEQUENTLY REVISED APPROXIMATELY TWO (2) YEARS ONE (1) MONTH POST INITIAL SURGERY DUE TO ASEPTIC LOOSENING OF IMPLANT AND PAIN. THE PATIENT HAD SOFT GLENOID BONE AND THE GLENOID POST WAS FOUND TO BE NOT WELL INTEGRATED. ALL IMPLANTS WERE REMOVED AND ANTIBIOTIC SPACERS WERE PLACE. NO INFECTION FINDINGS WERE FOUND. NO ADDITIONAL PATIENT IMPACT HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643621 PT HYBRID GLEN POST REGENEREX GENEREX TOTAL ANATOMIC SHOULDER PROSTHESIS KWT ZIMMER BIOMET, INC. 573810

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R