BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN MAR NEUT 64ODX28ID

    MDR report key: 3073395 · Received April 23, 2013

    Report

    Report Number
    1818910-2013-15808
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK000306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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

    VISUAL EXAMINATION OF THE RETURNED DEVICES CONFIRMS WEAR PATTERNS ON THE FEMORAL HEAD SUGGESTING THE LINER DISASSOCIATED FROM THE ACETABULAR COMPONENT. THEN ALLOWING THE FEMORAL HEAD TO CONTACT THE ACETABULAR CUP. HOWEVER, BECAUSE THE CUP WAS NOT RETURNED FOR EXAMINATION, THIS CANNOT BE CONFIRMED FOR MATCHING WEAR. THE RETURNED LINER ALSO SHOWS SIGNS OF UNUSUAL WEAR, FOUR OF THE ARDS HAVE BEEN FRACTURED, FURTHER INDICATING THE ECCENTRIC LOADING. ALSO NOTED WAS THE ABSENCE OF VISIBLE MARKS LEFT FROM A PROPER TAPER LOCK. PATIENT X-RAYS WERE NOT PROVIDED FOR REVIEW, PLACEMENT CANNOT BE COMMENTED UPON. THE FEMORAL HEAD APPEARS TO BE ECCENTRICALLY LOCATED WITHIN THE POLYETHYLENE INSERT OF THE ACETABULAR CUP SUGGESTING THE LINE HAS DISASSOCIATED FROM THE ACETABULAR SHELL. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. IT CANNOT BE DETERMINED, WITH THE INFORMATION PROVIDED, THAT THE COMPLAINT IS PRODUCT RELATED. REVIEW OF DEVICE HISTORY RECORDS FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    IT APPEARS FROM THE X-RAY THE THE INSERT HAS SLIPPED OUT OF THE CUP CAUSING THE HIP TO FAIL AND REQUIRE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174901 PINN MAR NEUT 64ODX28ID ACETABULAR LINER LPH DEPUY ORTHOPAEDICS VW5A41049

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention