BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11/13 S-ROM 40MM M SPEC+3

    MDR report key: 3973786 · Received August 1, 2014

    Report

    Report Number
    1818910-2014-24847
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    December 5, 2016
    Report Date
    August 4, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    K060031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES REQUIRED WERE NOT PROVIDED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED.DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME.SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    UDI: (B)(4).

    Description of Event or Problem · 1

    PPF ALLEGES METALLOSIS.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, LIMITED MOBILITY, PSEUDOTUMORS, AND TOXIC COBALT-CHROMIUM METAL DEBRIS TO BE RELEASED INTO THE TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450266 11/13 S-ROM 40MM M SPEC+3 S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS LPH DEPUY ORTHOPAEDICS INC US 2414025
    450267 11/13 S-ROM 40MM M SPEC+3 S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS LPH DEPUY ORTHOPAEDICS INC US 2414025
    450301 11/13 S-ROM 40MM M SPEC+3 S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS LPH DEPUY ORTHOPAEDICS INC US 2414025

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Required Intervention APEX HOLE ELIM POSITIVE STOP.| PINNACLE 100 HA ACET CUP 56MM.| PINNACLE MTL INS NEUT40IDX56OD.| S-ROM*SLEEVE PRX ZTT, 18D-SML.| SROM*STM ST,36+8L NK,18X13X160.