BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRX +4 10D 36IDX56OD

    MDR report key: 3181658 · Received June 21, 2013

    Report

    Report Number
    1818910-2013-19495
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 5, 2013
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK072963
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WAS REVISED TO ADDRESS DISASSOCIATION OF THE LINER FROM THE CUP, WHICH MAY HAVE LED TO DISLOCATION. DOI (B)(6) 2012; DOR (B)(6) 2013 (RIGHT HIP). EXAMINATION OF THE RETURNED DEVICES FINDS NOTHING OUTWARD TO SUGGEST PRODUCT ERROR. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. IT IS SUGGESTED THAT THE LINER DISASSOCIATED CAUSING A DISLOCATION. PER THE PROVIDED INFORMATION, AND EVIDENCE FOUND ON THE RETURNED LINER, THE PATIENT DISLOCATED AND AN UNSUCCESSFUL ATTEMPT(S) WAS MADE AT CLOSED REDUCTION. THE FEMORAL HEAD ASSOCIATED WITH THIS EVENT WAS NOT RETURNED. IT IS SUSPECTED THAT THE DEVICES WERE NOT FULLY ENGAGED WHEN FIRST IMPLANTED. FOLLOW-UP FOR ADDITIONAL EVENT INFORMATION WAS CONDUCTED UTILIZING WORK INSTRUCTION WI-7915 APPENDIX A. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE DISLOCATION EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. 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

    PATIENT WAS REVISED TO ADDRESS DISASSOCIATION OF THE LINER FROM THE CUP, WHICH MAY HAVE LED TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283140 ALTRX +4 10D 36IDX56OD ACETABULAR LINER LPH 1818910 DEPUY ORTHOPAEDICS, INC. 235983

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention