BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRX +4 NEUT 36IDX52OD

    MDR report key: 2163424 · Received June 10, 2011

    Report

    Report Number
    1818910-2011-10286
    Event Type
    Injury
    Date Received
    June 10, 2011
    Report Date
    May 11, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    K072963
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. FROM THE PROVIDED REPORT THE FEMORAL HEAD USED WITH THE DEPUY LINER IS COMPETITOR MANUFACTURED. THIS USE OF THE DEPUY DEVICE IS NOT RECOMMENDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    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

    MAUDE REPORT: PATIENT REPORTS SURGERY BECAUSE OF CRACKED/FAILURE HIP PROSTHETIC DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRX +4 NEUT 36IDX52OD 87 LPH LPH DEPUY ORTHOPAEDICS, INC. NA C5HGW1000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention