BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN SECTOR W/GRIPTION 60MM

    MDR report key: 3954593 · Received July 24, 2014

    Report

    Report Number
    1818910-2014-24101
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.1818910
    Product Code
    LPH
    PMA / PMN Number
    PK093646
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    LINER DISASSOCIATION DUE TO UNKNOWN CAUSES. WE SPECULATE IT WAS DUE TO NECK IMPINGEMENT. A 40X60 +4 NEUT. LINER WAS REPLACED, ALONG WITH A 40 +85 ROM. CERAMIC HEAD. VISUAL EXAMINATION OF THE RETURNED DEVICES FINDS EVIDENCE TO SUPPORT DISASSOCIATION OF THE LINER AND CUP WHILE IMPLANTED. THE RETURNED FEMORAL HEAD EXHIBITS SIGNS OF COMING INTO DIRECT CONTACT WITH THE ACETABULAR CUP, FURTHER SUPPORTING THE DISASSOCIATION. IN THIS CASE 5 OF THE ARD'S OF THE POLYETHYLENE LINER HAVE FRACTURED. THE WEAR FOUND ON THE ARTICULATING SURFACE OF THE ACETABULAR INSERT INDICATES THE FEMORAL HEAD WAS CENTRALLY LOADING THE DEVICE. PATIENT X-RAYS WERE REQUESTED BUT NOT PROVIDED. PLACEMENT CANNOT BE COMMENTED ON. IT WAS INITIALLY REPORTED THE LINER DISASSOCIATION WAS THOUGHT TO HAVE BEEN DUE TO STEM IMPINGEMENT. THE ACETABULAR CUP AND FEMORAL STEM WERE NOT RETURNED FOR EXAMINATION AND THIS CANNOT BE CONFIRMED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO RELATED OR SIMILAR REPORTS AGAINST THE PRODUCT/LOT CODE COMBINATIONS. REVIEW OF DEVICE HISTORY RECORDS FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED.

    Description of Event or Problem · 1

    LINER DISASSOCIATION DUE TO UNKNOWN CAUSES. WE SPECULATE IT WAS DUE TO NECK IMPINGEMENT. A 40X60 +4 NEUT. LINER WAS REPLACED, ALONG WITH A 40 +85 ROM. CERAMIC HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434147 PINN SECTOR W/GRIPTION 60MM HIP ACETABULAR CUP LPH DEPUY ORTHOPAEDICS, INC.1818910 EV9F21000

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention