BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRX +4 NEUT 36IDX54OD

    MDR report key: 4932793 · Received July 22, 2015

    Report

    Report Number
    1818910-2015-26275
    Event Type
    Injury
    Date Received
    July 22, 2015
    Date of Event
    July 21, 2015
    Report Date
    July 21, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    PK072963
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    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. 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 WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. 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.

    Additional Manufacturer Narrative · 1

    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 PAIN.

    Description of Event or Problem · 1

    UPDATE 11/19/2015 - PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MDR REPORTABILITY, THE REVISION OPERATIVE NOTE INDICATED PAIN AND LOOSE STEM. AS PREVIOUSLY STATED THE STEM IS REPORTED ON (B)(4) - THE STEM WILL BE CODED ON THAT COMPLAINT FOR LOOSENING. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING INVESTIGATION. THE COMPLAINT WAS UPDATED ON: 12/3/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474891 ALTRX +4 NEUT 36IDX54OD HIP ACETABULAR INSERT/LINER LPH DEPUY ORTHOPAEDICS INC US 224394

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention