BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINN MAR +4 10D 32IDX50OD

    MDR report key: 3954641 · Received July 24, 2014

    Report

    Report Number
    1818910-2014-24156
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 26, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK033273
    Adverse Event
    Yes
    Product Problem
    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. 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

    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

    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

    VISUAL EXAMINATION OF THE RETURNED LINER FINDS A MATERIAL FRACTURE NEAR THE RIM OF THE DEVICE. IT IS EVIDENT THAT THE EDGE OF THE LINER WAS LOADED BY THE FEMORAL HEAD AND PATIENT BODY WEIGHT WHILE IMPLANTED. CUP POSITIONING MORE VERTICAL THAN RECOMMENDED IS SUSPECTED TO HAVE BEEN A FACTOR. THE EDGE LOADING AND MATERIAL FRACTURE CONTRIBUTED TO A SUBSEQUENT DISASSOCIATION FROM THE ACETABULAR CUP. THERE ARE MACHINING LINES YET VISIBLE WITHIN THE INNER RADIUS OF THE LINER WHICH WOULD NOT BE AS OBVIOUSLY PRESENT HAD THE FEMORAL HEAD BEEN MORE CENTRALLY LOADED. THE RETURNED FEMORAL HEAD EXHIBITS SIGNS OF COMING INTO DIRECT CONTACT WITH THE ACETABULAR CUP, FURTHER SUPPORTING THE DISASSOCIATION. REVIEW OF PROVIDED PATIENT X-RAYS CONFIRMS THE CUP INCLINATION ANGLE WAS GREATER THAN RECOMMENDED PER THE SURGICAL TECHNIQUE. THE PATIENT IS CONSIDERED MORBIDLY OBESE. IT IS STATED IN THE WARNINGS AND PRECAUTIONS THAT EXCESSIVE PATIENT WEIGHT TENDS TO ADVERSELY AFFECT HIP REPLACEMENT IMPLANTS. A COMPLAINT DATABASE SEARCH FINDS NO ADDITIONAL REPORTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS. BASED ON THE INVESTIGATION A NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    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.

    Description of Event or Problem · 1

    (B)(4) SAME PATIENT, SAME SIDE. REVISION OF INLAY AND HEAD LEFT SIDE BECAUSE OF BREAKAGE OF PE INLAY. DATE OF SECOND REVISION: (B)(6) 2012. DATE OF THIRD REVISION: (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433487 PINN MAR +4 10D 32IDX50OD HIP ACETABULAR INSERT/LINER LPH DEPUY ORTHOPAEDICS, INC. 240792

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention