BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL HEAD

    MDR report key: 9416667 · Received December 5, 2019

    Report

    Report Number
    1818910-2019-120733
    Event Type
    Injury
    Date Received
    December 5, 2019
    Date of Event
    September 1, 2009
    Report Date
    November 13, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KXA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 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. 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

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

    Description of Event or Problem · 1

    THE LITERATURE ARTICLE ENTITLED, "DURABILITY OF SECOND-GENERATION EXTENSIVELY POROUS-COATED STEMS IN PATIENTS AGED 50 AND YOUNGER" WRITTEN BY JENNIFER A. MOYER BS, CATHERINE M. METZ MD, JOHN J. CALLAGHAN MD, DAVID W. HENNESSY BS, AND STEVE S. LIU MD PUBLISHED BY CLINICAL ORTHOPEDIC RELATED RESEARCH PUBLISHED ONLINE 1 SEPTEMBER 2009 WAS REVIEWED. THE ARTICLE'S PURPOSE WAS TO REPORT ON WHETHER SECOND-GENERATION EXTENSIVELY POROUS-COATED CEMENTLESS FEMORAL STEM IN PATIENTS YOUNGER THAN 50 YEARS OF AGE WOULD (1) BE DURABLE IN TERMS OF REVISIONS; (2) PROVIDE HIGH FUNCTIONAL SCORES AND REDUCE THIGH PAIN; AND (3) SHOW RADIOGRAPHIC DURABILITY OF FIXATION AND REDUCTION IN STRESS SHIELDING. DATA WAS COMPILED FROM 90 PATIENTS (89 HIPS) AGE 50 AND YOUNGER FROM JUNE 1994 TO DECEMBER 1999. THE ARTICLE REPORTS THAT THE PRODIGY FEMORAL STEM WAS MATED WITH EITHER NON-DEPUY ACETABULAR OR DEPUY DURALOC ACETABULAR COMPONENTS. THE ARTICLE DOES NOT SPECIFY WHICH ACETABULAR COMPONENTS CAN BE ASSOCIATED WITH THE SPECIFIC ADVERSE EVENTS, AND THE ARTICLE DOES NOT PROVIDE ADEQUATE INFORMATION TO DETERMINE ACCURATE QUANTITIES. ARTICLE STATES NO INFECTIONS OR LOOSE COMPONENTS. DEPUY PRODUCTS UTILIZED: PRODIGY STEM, DURALOC CUP (SCREWS WERE USED IN ALL CASES) AND POLY LINER, METAL HEAD. ADVERSE EVENTS: MILD THIGH PAIN (NO INTERVENTIONS, ASSOCIATED WITH FEMORAL STEM), DISLOCATION (TREATED BY REVISION AND HEAD AND LINER EXCHANGE), PERIPROSTHETIC FEMORAL FRACTURE (TREATED BY STEM REVISION), LINER WEAR (TREATED BY REVISION WITH HEAD AND LINER EXCHANGE), LINER DISASSOCIATION (TREATED BY REVISION OF HEAD, LINER, AND CUP EXCHANGE), OSTEOLYSIS (RADIOGRAPHIC FINDINGS, NO INTERVENTIONS, COMMONLY ASSOCIATED WITH LINER WEAR), FEMORAL STRESS SHIELDING (RADIOGRAPHIC FINDINGS, NO INTERVENTIONS), ACETABULAR RADIOLUCENCY'S (RADIOGRAPHIC FINDINGS, NO LOOSENING'S, NO INTERVENTIONS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1211123 UNKNOWN HIP FEMORAL HEAD HIP FEMORAL HEAD KXA DEPUY ORTHOPAEDICS INC US NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention