BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMP RVS TRAY CO 44MM

    MDR report key: 6414980 · Received March 17, 2017

    Report

    Report Number
    0001825034-2017-01684
    Event Type
    Malfunction
    Date Received
    March 17, 2017
    Date of Event
    February 20, 2017
    Report Date
    September 11, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PK113069
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. 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(S) IS/ARE REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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). MEDICAL THERAPY: E1 44-36 STD HMRL BRNG; CAT#: EP-115393 LOT#: 980190. SMALL DIA CEMENT PLUG 10MM, CAT#: 414994 LOT#: 880730. RINGLOC+ REPLACEMENT RING SZ21, CAT#: 106021 LOT#: 672490. COMP RVS CNTRL 6.5X30MM ST/RST, CAT#: 115396 LOT#: 576900. COMP LK SCR 3.5HEX 4.75X20 ST, CAT#: 180551 LOT#: 045990. COMP RVS CNTRL 6.5X25MM ST/RST, CAT#: 115395 LOT#: 485080. COMP NLK SCR 3.5HEX 4.75X30 ST, CAT#: 180560 LOT#: 165840. COMP RVRS 25MM BSPLT HA+ADPTR, CAT#: 010000589 LOT#: 600350. COMP LK SCR 3.5HEX 4.75X15 ST, CAT#: 180550 LOT#: 094560. COMP RVRS SHLDR GLNSP STD 36MM, CAT#: 115310 LOT#: 602490. COMPR 6MM HUM FRACT STEM PPS, CAT#: 12-113556 LOT#: 588580. 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 LOCKING RING BECAME BENT UPON INSERTION INTO THE HUMERAL TRAY. IT WAS REPLACED WITH A LOCKING RING FROM ANOTHER SET. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195625 COMP RVS TRAY CO 44MM PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A 163630

    Patients

    Seq Age Sex Outcome Treatment
    1