BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIFIT ABC PSL M/S SHELL SIZE 54

    MDR report key: 1519773 · Received October 30, 2009

    Report

    Report Number
    2249697-2009-00746
    Event Type
    Injury
    Date Received
    October 30, 2009
    Date of Event
    September 9, 2008
    Report Date
    September 30, 2009
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K963946
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER DEVICES WERE ALSO LISTED IN THIS REPORT: ABC ALUMINA CERAMIC INSERT, CAT# 2047-3254; LOT 1526741129. OMNIFIT HA C-TAPER HIP STEM, CAT# 6017-0830; 28878501. ABC ALUMINA C-TAPER HEAD, CAT# 17-3205; LOT PC6000130. 6.5 CANCELLOUS BONE SCREW 30MM, CAT# 2030-6530-1; LOT 28086902. 6.5 CANCELLOUS BONE SCREW 25MM, CAT# 2030-6525-1; LOT 25971808. 6.5 CANCELLOUS BONE SCREW 16MM, CAT# 2030-6516-1; LOT 27508304. IT CANNOT BE DETERMINED WHICH, IF ANY, OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, AND IF AVAILABLE, IT WILL BE SUBMITTED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED: "PATIENT PRESENTED WITH DEEP JOINT INFECTION AND UNDERWENT REVISION SURGERY". THE EXACT IMPLANTATION DATE WAS NOT PROVIDED, HOWEVER, IT WAS INDICATED THAT THE REPORTED DEVICES WERE IMPLANTED IN 1997.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIFIT ABC PSL M/S SHELL SIZE 54 IMPLANT LPH STRYKER ORTHOPAEDICS MAHWAH NA 28469101

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention