BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN MAR +4 10D 40IDX58OD

    MDR report key: 2955029 · Received February 11, 2013

    Report

    Report Number
    1818910-2013-12115
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 8, 2013
    Manufacturer
    DEPUY SYNTHES
    Product Code
    LPH
    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

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. PROVIDED PATIENT DEMOGRAPHICS INDICATE THAT THE PATIENT IS A (B)(6) MALE, CALCULATED BMI OF 25.67. ACTIVITY LEVEL IS NOT KNOWN. A REVIEW OF DEVICE HISTORY RECORDS FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A SEARCH OF THE COMPLAINTS DATABASES FINDS TWO OTHER REPORTS AGAINST THE 947624653/1877848 PRODUCT/LOT CODE COMBINATION. IT IS CONFIRMED THAT ONE OF THE TWO OTHER REPORTS FOUND IS FOR THE SAME PATIENT AND SAME IMPLANT. THE ONE OTHER REPORT FOUND THE ITEM REPORTED WAS NON-CONTRIBUTING TO THE REPORTED EVENT AND IS THEREFORE, NOT SIMILAR TO THIS REPORT. NO OTHER REPORTS FOUND AGAINST THE REMAINDER OF THE PROVIDED PRODUCT/LOT CODE COMBINATIONS. REVIEW OF REVISION OPERATIVE NOTES AND X-RAYS FINDS THAT THE HIP WAS FOUND TO BE STABLE AND THE IMPLANTS WERE NOT LOOSE. PHYSICIAN STATES THAT THERE WAS CHRONIC TROCHANTERIC BURSITIS AND AN EFFUSION IN THE JOINT PRESENT. IT CANNOT BE DETERMINED, WITH THE INFORMATION PROVIDED, THAT THE COMPLAINT IS PRODUCT RELATED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED.

    Description of Event or Problem · 1

    CLINICAL STUDY (B)(6), RIGHT SIDE. SITE 3. THE SUBJECT REPORTED WITH DISLOCATION AND IMPINGEMENT IN 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59878 PINN MAR +4 10D 40IDX58OD ACETABULAR POLY LINER LPH DEPUY SYNTHES CV6CS1000

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention