BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTAMET MTL INS NEUT 36MM 62OD

    MDR report key: 1870893 · Received October 7, 2010

    Report

    Report Number
    1818910-2010-07034
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 7, 2010
    Manufacturer
    DEPUY INTL. LTD.
    Product Code
    KWA
    PMA / PMN Number
    K073504
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    (B)(4) REPORTS: THE PATIENT PRESENTED WITH RECURRENT DISLOCATION - 3 TIMES. IT WAS DECIDED THAT SURGICAL INTERVENTION WAS NECESSARY TO SOLVE THE PROBLEM. THE STEM (SUMMIT) WAS LEFT IN SITU AND THE PINNACLE SECTOR CUP WAS ALSO LEFT IN SITU. THE ULTAMET ACETABULAR LINER WAS REMOVED AND REPLACED WITH A 36MM +4 10 DEGREE PINNACLE POLY LINER. THE 8.5MM 36MM FEMORAL HEAD WAS REMOVED TO A 36MM ULTAMET HEAD 15.5MM. INTRA OPERATIVELY THERE WERE SMALL SIGNS OF METALLOSIS ALTHOUGH NOT DEEMED SIGNIFICANT. TISSUE SPECIMENS WERE SENT FOR ANALYSIS. JOINT CAPSULE APPEARED INFLAMED AND LARGE AMOUNT OF FLUID WAS SUCKED FROM THE JOINT. A SPECIMEN OF THE FLUID WAS ALSO SENT FOR ANALYSIS. JOINT APPEARED TO BE UNSTABLE AND IT WAS DECIDED TO INCREASE HEAD LENGTH AND USE AN OFFSET LINER TO ACHIEVE STABILITY. UPON CLOSURE THE HIP APPEARED STABLE WITH ALL COMPONENTS IN SITU. FACILITY IS UNWILLING TO PROVIDE PATIENT INFORMATION. EXAMINATION OF THE RETURNED PRODUCT CONFIRMED THE REPORTED EVENT. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY OTHER REPORTS AGAINST THE PRODUCT AND LOT COMBINATION. A REVIEW OF THE DEVISE HISTORY REPORT DID NOT REVEAL ANY ANOMALIES REGARDING THE REPORTED EVENT AGAINST THE PRODUCT AND LOT COMBINATION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT: HOWEVER EVIDENCE SUGGESTS THAT THE INSTABILITY OF THE HIP WAS LIKELY THE CAUSE OF FAILURE. THIS IS SURGERY RELATED BUT NOT NECESSARILY IMPLANT RELATED AND THEREFORE THE COMPLAINT WAS DEEMED UNJUSTIFIED WITH RESPECT TO THE IMPLANT. BASED ON THE INVESTIGATION FINDINGS, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED WITH RECURRENT DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTAMET MTL INS NEUT 36MM 62OD 87 KWA, LZO KWA DEPUY INTL. LTD. NA 2232636

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention