BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN MAR LIP LNR 28IDX48OD

    MDR report key: 2881368 · Received December 20, 2012

    Report

    Report Number
    1818910-2012-28525
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    December 4, 2012
    Report Date
    December 4, 2012
    Manufacturer
    DEPUY WARSAW
    Product Code
    LPH
    PMA / PMN Number
    K000306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 REMAIN REPORTEDLY IMPLANTED. X-RAYS RECEIVED AND REVIEWED. X-RAYS ARE NOT DATED. FEMORAL HEAD APPEARS TO BE ECCENTRICALLY LOCATED WITHIN THE POLYETHYLENE INSERT OF THE ACETABULAR CUP SUGGESTING POLY WEAR. THE ACETABULAR CUP DOES NOT APPEAR TO BE PLACE AT THE SUGGESTED ANTEVERSION ANGLE; HOWEVER, THE ANGULAR DEGREE CANNOT BE DETERMINED. SUSPECTED MALPOSITIONING OF THE CUP MAY HAVE LED TO THE DESCRIBED POLY WEAR. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. 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. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED DEVICES FINDS EVIDENCE TO SUPPORT THE PREVIOUS X-RAY EXAMINATION FINDING OF EDGE LOADING. IN THIS CASE A PORTION OF THE RIM OF THE POLYETHYLENE LINER HAS FRACTURED. IT IS EVIDENT THAT THE EDGE OF THE LINER WAS LOADED BY THE FEMORAL HEAD AND PATIENT BODY WEIGHT WHILE IMPLANTED. 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 EDGE LOADING OF THE LINER HAS PLACED PRESSURES ON THE MATERIAL NEAR THE RIM THAT WERE NOT INTENDED LEADING TO A FRACTURE OF THE MATERIAL AND POSSIBLE DISASSOCIATION OF THE LINER FROM THE CUP. THE CUP WAS NOT RETURNED FOR EXAMINATION. IT IS SUSPECTED THAT THE ACETABULAR CUP WAS POSITIONED MORE VERTICALLY THAN RECOMMENDED BY SURGICAL TECHNIQUE CONTRIBUTING TO THE EDGE LOADING. PREVIOUS REVIEW OF DEVICE HISTORY RECORDS FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE PERFORMED INVESTIGATION, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED DEVICES FINDS EVIDENCE TO SUPPORT THE PREVIOUS X-RAY EXAMINATION FINDING OF EDGE LOADING. IN THIS CASE A PORTION OF THE RIM OF THE POLYETHYLENE LINER HAS FRACTURED. IT IS EVIDENT THAT THE EDGE OF THE LINER WAS LOADED BY THE FEMORAL HEAD AND PATIENT BODY WEIGHT WHILE IMPLANTED. 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 EDGE LOADING OF THE LINER HAS PLACED PRESSURES ON THE MATERIAL NEAR THE RIM THAT WERE NOT INTENDED LEADING TO A FRACTURE OF THE MATERIAL AND POSSIBLE DISASSOCIATION OF THE LINER FROM THE CUP. THE CUP WAS NOT RETURNED FOR EXAMINATION. IT IS SUSPECTED THAT THE ACETABULAR CUP WAS POSITIONED MORE VERTICALLY THAN RECOMMENDED BY SURGICAL TECHNIQUE CONTRIBUTING TO THE EDGE LOADING. PREVIOUS REVIEW OF DEVICE HISTORY RECORDS FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE PERFORMED INVESTIGATION, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    THE PATIENT X-RAYS REVEAL SIGNIFICANT WEAR OF THE POLYETHYLENE LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINN MAR LIP LNR 28IDX48OD DEPUY HIP IMPLANT LPH DEPUY WARSAW EN7H61000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention