BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS SHLDR GLNSP STD 36MM

    MDR report key: 6971637 · Received October 24, 2017

    Report

    Report Number
    0001825034-2014-08654
    Event Type
    Injury
    Date Received
    October 24, 2017
    Date of Event
    November 6, 2014
    Report Date
    October 20, 2017
    Manufacturer
    ZIMMER BIOMET ORTHOPEDICS
    Product Code
    PAO
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: PART # XL-115363¸ LOT# 507320, ARCOM XL 44-36 STD HMRL BRNG. PART# 115340, LOT # 062320, COMP RVS HMRL TI TRAY 44 MM. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS WITH THE SAME PART AND LOT WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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 · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO INFERIOR POLY WEAR FROM A DISLOCATION RELATED TO A FALL. THE HUMERAL TRAY, BEARING AND GLENOSPHERE WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751127 COMP RVRS SHLDR GLNSP STD 36MM PROSTHESIS, SHOULDER PAO ZIMMER BIOMET ORTHOPEDICS N/A 504470

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R