BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRX +4 NEUT 36IDX58OD

    MDR report key: 8478934 · Received April 3, 2019

    Report

    Report Number
    1818910-2019-89544
    Event Type
    Injury
    Date Received
    April 3, 2019
    Date of Event
    March 8, 2019
    Report Date
    March 15, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910 
    Product Code
    LPH
    UDI-DI
    10603295016519
    PMA / PMN Number
    K062148
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER RELATED REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT CODE/LOT NUMBER COMBINATION 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH , A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR INITIAL HIP DISLOCATION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO DEVICE AND THERE IS A REMOTE POSSIBILITY IT IS RELATED TO PROCEDURE. DOI: (B)(6) 2018; DOE: (B)(6) 2019; (LEFT HIP). TREATED VIA CLOSED REDUCTION. 136536240 8642059, HEAD; 122136458 J0018T, LINER; 550536, 8657788, S-ROM SLEEVE; 563620, 8934901, S-ROM STEM; 121701058 8659264, CUP; 124603000 D18091938, HOLE ELIMINATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272572 ALTRX +4 NEUT 36IDX58OD PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS LPH DEPUY ORTHOPAEDICS, INC. 1818910  J0018T 10603295016519

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention