BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCOM XL 44-36 STD HMRL BRNG

    MDR report key: 6849175 · Received September 7, 2017

    Report

    Report Number
    0001825034-2017-06990
    Event Type
    Malfunction
    Date Received
    September 7, 2017
    Date of Event
    July 12, 2017
    Report Date
    January 24, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    PAO
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERAPY DATE - (B)(6) 2017. COMP RVS TRAY CO 44MM, CATALOG # 115370, LOT # 418310. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPOTS WERE FILLED FOR THIS EVENT: 0001825034 - 2017 - 06991.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS- COMP RVS TRAY CO 44MM CATALOG#: 115370 LOT#: 418310, COMP RVRS 25MM BSPLT HA+ADPTR CATALOG#: 010000589 LOT#: 129050, COMP RVS TRAY CO 44MM CATALOG#: 115370 LOT#: 571090, COMP PRIMARY STEM 15MM MINI CATALOG#: 113635 LOT#: 74306, COMP RVSR SHLDR GLNSP +3 36MM CATALOG#: 115313 LOT#: 913190, COMP LK SCR 3.5HEX 4.75X25 ST CATALOG#: 180552 LOT#: 641720, COMP LK SCR 3.5HEX 4.75X30 ST CATALOG#: 180553 LOT#: 876310, COMP LK SCR 3.5HEX 4.75X15 ST CATALOG#: 180550 LOT#: 494330, COMP RVS CNTRL 6.5X25MM ST/RST CATALOG#: 115395 LOT#: 566410, ARCOM XL 44-36 STD HMRL BRNG CATALOG#: XL-115363 LOT#: 927310. 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. 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 IS REPORTED THAT THE SURGEON HAD DIFFICULTY INSERTING THE BEARING DUE TO THE LOCKING RING ON THE HUMERAL TRAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL SHOULDER ARTHROPLASTY, THE SURGEON WAS UNABLE TO ASSEMBLE THE HUMERAL BEARING INTO THE HUMERAL TRAY. A NEW TRAY AND BEARING WERE UTILIZED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630176 ARCOM XL 44-36 STD HMRL BRNG PROSTHESIS, SHOULDER PAO BIOMET ORTHOPEDICS N/A 927520

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR