BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA TT CUP, DIA.64MM

    MDR report key: 4239027 · Received November 10, 2014

    Report

    Report Number
    3008021110-2014-00021
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 24, 2014
    Report Date
    October 30, 2014
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LPH
    PMA / PMN Number
    K112898
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CHECK OF THE MANUFACTURING AND STERILIZATION CHARTS OF THE CUP INVOLVED (LOT # 201100713 STER.1100034) DID NOT SHOW ANY PRE-EXISTING ANOMALY ON THE PIECES RELEASED ON THE MARKET. WE RECEIVED NO OTHER SIGNALINGS ON THIS LOT # OF PRODUCT; IN PARTICULAR, A TOTAL OF 5 DELTA TT CUPS WERE MANUFACTURED WITH THE LOT # 201100713 STER.1100334, AND BY OUR CHECKS 3 OF THEM HAVE BEEN SURELY IMPLANTED. WE RECEIVED A PHOTO OF THE EXPLANTED CUP (DEVICE NOT RETURNED TO US) AND A X-RAY RELATED TO THE PRE-OP OF THE REVISION (SURGERY PERFORMED ON (B)(6) 2014). THE PHOTO OF THE EXPLANTED CUP SHOWS A PRESENCE OF FIBROUS TISSUE ONTO THE CUP WITH NO SIGNIFICANT BONE INGROWTH. THE X-RAY OF THE INCIDENT SHOWS THAT THERE ARE RADIOLUCENT LINES AROUND THE CUP, CONFIRMING A LYSIS OF THE CUP FROM THE ACETABULAR BONE. THE POSITION OF THE CUP APPEARS TO BE TOO HORIZONTAL; WITHOUT THE X-RAYS RELATED TO THE POST-OP OF THE ORIGINAL SURGERY, WE CANNOT MAKE A COMPARISON BETWEEN THE ORIGINAL POSITION OF THE CUP AND ITS POSITION SOON BEFORE THE REVISION. BASED ON THE SURGEON COMMENTS "HE DID NOT NOTE ANY SIGN OF INFECTION DURING THE REVISION ((B)(6) 2014), HOWEVER, HE DID BACTERIAL SWABS, THE RESULT IS UNKNOWN", WE BELIEVE THAT AT MOST A LOW GRADE INFECTION COULD HAVE OCCURRED; WE CANNOT DEFINE HOW MUCH THE CUP POSITIONING (TOO HORIZONTAL BEFORE THE REVISION) HAVE CONTRIBUTED TO THE ISSUE. WE ARE AWARE OF 3 CASES OF CONFIRMED INFECTION WITH A DELTA TT CUP, PLUS 2 CASES OF "SUSPECTED SEPTIC LOOSENING" OF A DELTA TT CUP. FOR ALL THESE CASES, THE DEVICES INVOLVED WERE REGULARLY STERILIZED BEFORE BEING PLACED ON THE MARKET. (B)(4). NO CORRECTIVE ACTIONS HAVE BEEN PLANNED. LIMACORPORATE WILL KEEP MONITORED THE MARKET. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    DELTA TT CUP IMPLANTED ON (B)(6) 2012. REASON FOR REVISION NOTED BY SURGEON: UNSTABLE CUP, POOR POSITIONING OF IMPLANT CAN BE NOTED ON X-RAYS. SURGEON ALSO COMMENTED THAT THERE IS NO OSSEOINTEGRATION ON CUP, ONLY FIBROUS TISSUE. HE DID NOT NOTE ANY SIGN OF INFECTION DURING THE REVISION ((B)(6) 2014), HOWEVER, HE DID BACTERIAL SWABS, THE RESULT IS UNKNOWN. SURGEON REVISED USING A STRYKER REVISION ACETABULAR CUP. THE EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722678 DELTA TT CUP, DIA.64MM LPH, MBL LPH LIMACORPORATE S.P.A. 5552.15.640 201100713-1100034

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention