BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN 100 HA ACET CUP 60MM

    MDR report key: 2240689 · Received September 9, 2011

    Report

    Report Number
    1818910-2011-17711
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    August 29, 2011
    Report Date
    August 29, 2011
    Manufacturer
    DEPUY WARSAW
    Product Code
    LPH
    PMA / PMN Number
    K031495
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    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

    EXAMINATION OF THE RETURNED PRODUCTS (BY CERAMTEC) CONFIRMED THE REPORTED EVENT: HOWEVER THE PRODUCTS WERE SENT TO CERAMTEC, EVALUATED AND CONFIRMED THE REPORTED EVENT. REVIEW OF THE PROVIDED F X-RAYS BY (B)(6), NOTED THE CUP PLACEMENT APPEARED TO BE SLIGHTLY VERTICAL. THE INVESTIGATION CONCLUDED THE ACETABULAR CUP PLACEMENT APPEARS TO BE SLIGHTLY VERTICAL: HOWEVER, THIS OBSERVATION MUST BE CLARIFIED WITH A COMMENT REGARDING A LACK OF VISIBLE LANDMARKS IN THE FILM. IT IS DIFFICULT TO APPRECIATE MANY OF THE DETAILS REGARDING IMPLANT PLACEMENT. A VERTICAL CUP POSITION LEADING TO EDGE LOADING AND RECURRING SUBLUXATION PROBABLY CAUSED THE NOISE PHENOMENON. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR. 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

    REVISION DUE TO SQUEAKING. REVISED 30 AUG 2011 TO A 32MM POLY LINER AND 32MM REVISION CERAMIC TS HEAD. COMPONENTS WILL BE RETURNED AND CURRENTLY BEING DECONTAMINATED. LEFT HIP. DATE OF PRIMARY: (B)(6) 2009. DATE OF REVISION: (B)(6) 2011. UPDATE FROM AUSTRALIA SURGEON COMMENTED THAT THE CUP POSITION WAS VERY STEEP AND HAS PROBABLY CONTRIBUTED TO THE INCIDENCE OF SQUEAK HEARD HERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINN 100 HA ACET CUP 60MM ACETABULAR CUP LPH DEPUY WARSAW C2EFM1000

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention