BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRX +4 10D 40IDX58OD

    MDR report key: 4366036 · Received December 29, 2014

    Report

    Report Number
    1818910-2014-35227
    Event Type
    Injury
    Date Received
    December 29, 2014
    Date of Event
    December 3, 2014
    Report Date
    December 3, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LPH
    PMA / PMN Number
    PK072963
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE LOT CODES 486261 AND 7840033. A SEARCH OF THE COMPLAINT DATABASE SEARCH FINDS ONE ADDITIONAL REPORTED INCIDENT AGAINST LOT CODE BS5CEA SINCE ITS RELEASE FOR DISTRIBUTION; HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. CORRECTIVE ACTION WAS NOT INDICATED.DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS A MALPOSITIONED CUP AND CHRONIC DISLOCATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854449 ALTRX +4 10D 40IDX58OD HIP ACETABULAR INSERT/LINER LPH DEPUY ORTHOPAEDICS, INC. 1818910 486261

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention