BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRX NEUT 32IDX50OD

    MDR report key: 12440607 · Received September 8, 2021

    Report

    Report Number
    1818910-2021-19677
    Event Type
    Injury
    Date Received
    September 8, 2021
    Date of Event
    March 12, 2021
    Report Date
    March 12, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    UDI-DI
    10603295016106
    PMA / PMN Number
    K102423
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED, AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT ==> THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MATERIAL, MANUFACTURING, INSPECTION OR STERILE PROCESSING THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    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.

    Description of Event or Problem · 1

    COMPASS CASE (B)(4) REPORTS: THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. SURGEON REMOVED HEAD AND LINER, LEAVING EXISTING CUP AND STEM (1217-22-050 L-J8920U & 1010-12-010 L-HW5858). CONVERTED TO PINNACLE MDM. NO SURGICAL DELAY. DOI: (B)(6) 2021, DOR: (B)(6) 2021, RIGHT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1338306 ALTRX NEUT 32IDX50OD PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS LPH DEPUY ORTHOPAEDICS INC US 1221-32-050 J48D61 10603295016106

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention ALTRX NEUT 32IDX50OD.| DELTA CER HEAD 12/14 32MM +5.| ALTRX NEUT 32IDX50OD| DELTA CER HEAD 12/14 32MM +5