BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMP RVS TRAY CO 44MM

    MDR report key: 6731841 · Received July 21, 2017

    Report

    Report Number
    0001825034-2017-05071
    Event Type
    Malfunction
    Date Received
    July 21, 2017
    Date of Event
    June 21, 2017
    Report Date
    February 8, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PK113069
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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). THE FOLLOWING REPORT IS SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: COMP PRIMARY STEM 14MM MINI LOT#579780 ITEM#113634, COMP RVS CNTRL SCR 6.5X20MM ST LOT#704630 ITEM#115380, COMP RVRS SHDR GLEN BSPLT +HA LOT#708070 ITEM#115330, COMP LK SCR 3.5HEX 4.75X25 ST LOT#122060 ITEM#180552, COMP LK SCR 3.5HEX 4.75X25 ST LOT#122060 ITEM#180552, COMP LK SCR 3.5HEX 4.75X15 ST LOT#494290 ITEM#180550, COMP NLK SCR 3.5HEX 4.75X15 ST LOT#095580 ITEM#180557. THE REPORTED EVENT IS CONFIRMED. PRODUCTS WERE RETURNED; VISUAL INSPECTION CONFIRMED THE LOCKING RING WAS BENT AND HUMERAL BEARING DAMAGE IDENTIFIED AT SLOT OPENING, VISIBLE GOUGES IN POLY. DIMENSIONAL MEASUREMENTS TAKEN FOR RINGLOC WERE FOUND WITHIN MANUFACTURING SPECIFICATIONS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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)(6). (B)(4). CONCOMITANT PRODUCTS ¿ ARCOM XL 44-36 STD HMRL BRNG, CAT#: XL-115363 LOT#: 145420. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SHOULDER ARTHROPLASTY THE LEFT SIDE OF THE LOCKING RING OPENING WAS NOT ROTATING LIKE THE RIGHT. THE HUMERAL BEARING WAS THEN REMOVED AND REPLACED ALLOWING THE PROCEDURE TO BE COMPLETED WITH MINIMAL DELAY. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511844 COMP RVS TRAY CO 44MM PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A 418220

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR