BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVS HMRL TI TRAY 44MM

    MDR report key: 7757072 · Received August 7, 2018

    Report

    Report Number
    0001825034-2018-04674
    Event Type
    Injury
    Date Received
    August 7, 2018
    Date of Event
    September 13, 2011
    Report Date
    September 11, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: 115330  COMP RVRS SHDR GLEN BSPLT +HA 283220;  180501  COMP LOCKING SCREW 4.75X20MM 048230 ; 113654  COMP PRIMARY STEM 14MM STD 953080 ; 115380  COMP RVS CNTRL SCR 6.5X20MM ST 042060 ; 115310  COMP RVRS SHLDR GLNSP STD 36MM 355680 ; 180502  COMP LOCKING SCREW 4.75X25MM 552500 ; 118001  VERSA-DIAL/COMP TI STD TAPER 222080 ; XL-115363 ARCOM XL 44-36 STD HMRL BRNG 095350 . CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, PRODUCT LOCATION UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT OPEN TREATMENT AND REVISION OF A LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY DUE TO GREATER TUBEROSITY FRACTURE APPROXIMATELY FOUR (4) MONTHS POST PRIMARY SURGERY. THE HUMERAL BEARING AND TRAY WERE REMOVED AND REPLACED. A THICKER TRAY WAS UTILIZED TO TIGHTEN UP THE SHOULDER JOINT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597462 COMP RVS HMRL TI TRAY 44MM PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 557860

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R