BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURALOC CONST LINER 60/72X32

    MDR report key: 3110759 · Received May 14, 2013

    Report

    Report Number
    1818910-2013-17011
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 9, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS
    Product Code
    JDI
    PMA / PMN Number
    PP960054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. A REVIEW OF DEVICE HISTORY RECORDS FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF PROVIDED PATIENT X-RAYS BY DEPUY CPD FINDS DISLOCATION OF THE PROXIMAL FEMUR NOTED. RETAINING RING ALSO DISASSOCIATED FROM THE LINER/CUP. FROM AN ENGINEERING STANDPOINT NO OTHER CONCLUSIONS CAN BE DRAWN FROM THE X-RAY. ADDITIONALLY, RESEARCH USING THE (B)(4) INDICATES THAT SEVERAL OTHER DEVICES FROM THE REPORTED LOTS HAVE BEEN DELIVERED AND ARE CONSIDERED SUCCESSFULLY IMPLANTED AS NO OTHER REPORTS HAVE BEEN RECEIVED. 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 THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    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

    REASON FOR REVISION: RECURRENT DISLOCATION. ON X-RAY IT WAS NOTED THAT THE CONSTRAINED LINER LOCKING RING HAD DISSOCIATED AND THE PATIENT HAD DISLOCATED. PATIENT UNDERWENT SURGERY WHERE THE NECK ANTIVERSION WAS ADJUSTED AND ANOTHER CONSTRAINED LINER IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213142 DURALOC CONST LINER 60/72X32 ACETABULAR LINER JDI DEPUY ORTHOPAEDICS Z54JJ1000

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention