BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHARNLEY LPW CUP 22.225/47MM

    MDR report key: 1895104 · Received November 5, 2010

    Report

    Report Number
    1818910-2010-08401
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 7, 2010
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    JDI
    PMA / PMN Number
    K871867
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    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

    DEPUY (B)(4) REPORTS: FAILED ELITE PLUS THR 10 YEARS POST-IMPLANTATION. FOLLOWING INVESTIGATION BY BIOENGINEERING, NOTIFICATION WAS RECEIVED THAT: CONCLUSION: PRODUCT RETURNED, NO X-RAYS. NO VISIBLE DAMAGE TO STEM EXCEPT FOR SOME POST-RETRIEVAL MARKS AND A SMALL POLISHED AREA UNDER THE MEDIAL COLLAR. SOME DAMAGE AT BASE OF HEAD ON TAPER AND NECK. THIS IS PRESUMED TO BE RETRIEVAL DAMAGE. HEAD IS VISUALLY UNDAMAGED. HEAD FITS SNUGLY IN CUP. CONTACT AREA IS VISIBLE IN CUP AND EDGE CAN BE FELT. THE CUP IS DAMAGE FROM INTRODUCER HOLE, THROUGH LASER MARKING TO POLE OF THE CUP. THIS IS THOUGHT TO BE RETRIEVAL DAMAGE. NO IMPINGEMENT OF THE NECK ON THE CUP IS VISIBLE. CUP HAS 2 CRACKS VISIBLE ON POSTERIOR SURFACE. THESE ARE THOUGHT TO BE RETRIEVAL DAMAGE. BONE CEMENT IS DELAMINATING FROM CEMENT. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY OTHER REPORTS AGAINST THE PRODUCT AND LOT COMBINATION. A REVIEW OF THE DEVICE HISTORY REPORT DID NOT REVEAL ANY ANOMALIES REGARDING THE REPORTED EVENT AGAINST THE PRODUCT AND LOT COMBINATION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT. BASED ON THE INVESTIGATION FINDINGS, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE PT WAS REVISED TO ADDRESS SUBSIDENCE OF THE STEM AND SUBSEQUENT LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHARNLEY LPW CUP 22.225/47MM 87JDI JDI DEPUY INTERNATIONAL, LTD. NA XGH-86

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention