BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPR SRS SEAS HMRL HEAD 48X19

    MDR report key: 8852823 · Received August 1, 2019

    Report

    Report Number
    0001825034-2019-03337
    Event Type
    Injury
    Date Received
    August 1, 2019
    Date of Event
    July 9, 2019
    Report Date
    September 26, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWT
    PMA / PMN Number
    K111746
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE COULD NOT BE DETERMINED; HOWEVER, IT IS IDENTIFIED THAT CONTRIBUTING FACTORS ARE A HISTORY OF CHONDROSARCOMA WITH SEGEMENTAL RESECTION OF TUMOR INVOLVING ROTATOR CUFF AND RECENT SUPERFICIAL INFECTION AND DEHISCENCE. 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 AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 211223, COMPR SRS TUMOR BDY - 71MM, 484220; 211228, COMPR SRS MOD RGX AUG - SM, 216410; 211258, COMPR SRS MOD STEM - 9X75MM, 314970; 211226, COMPR SRS IC SEG - 90MM, 938550; B000-0185, 6M9704, STRYKER ORTHOPAEDICS; 6197-1-001, TMZ046, STRYKER ORTHOPAEDICS. REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS 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 PATIENT'S LEFT SHOULDER DISLOCATED 3 MONTHS POST IMPLANTATION. PROSTHESIS WAS CEMENTED IN, SHOULDER REDUCED, AND THE REMAINING ROTATOR CUFF WAS THEN ATTACHED TO THE PROSTHESIS. THE TRICEPS WAS THEN SEWN INTO THE PEC AND LAT DORSI TENDONS AROUND THE HUMOROUS TO HELP STABILIZE. THE WOUND WAS WASHED OUT AND CLOSED IN LAYERS. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645997 COMPR SRS SEAS HMRL HEAD 48X19 PROSTHESIS, SHOULDER KWT ZIMMER BIOMET, INC. N/A 672550

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R