BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP

    MDR report key: 5224717 · Received November 15, 2015

    Report

    Report Number
    0001825034-2015-04649
    Event Type
    Injury
    Date Received
    November 15, 2015
    Report Date
    October 20, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT - UNKNOWN. DEVICE CODE - UNKNOWN. EXPIRATION DATE - UNKNOWN. DATE IMPLANTED - UNKNOWN. DATE EXPLANTED - UNKNOWN. INITIAL REPORTER - THE ARTICLE WAS WRITTEN BY KIRILL GROMOV, MERIDITH GREENE, CHRISTOPHER BARR, JAMES HUDDLESTON, ROGER EMERSON, EDUARDO GARCIA-CIMBRELO, PETER GEBUHR, HENRIK MALCHAU AND ANDERS TROELSEN. PMA/510(K) NUMBER. MANUFACTURE DATE ¿ UNKNOWN. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH AS THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE IS (OR MAY BE) NEEDED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING A REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND FURTHER MEDWATCH REPORTS WILL BE SUBMITTED, IF NECESSARY.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE ENTITLED, "PRESENCE OF ACETABULAR DYSPLASIA INCREASES RISK FOR MALPOSITIONING OF THE ACETABULAR COMPONENT IN PRIMARY HIP ARTHROPLASTY." A TOTAL OF 945 PATIENTS FROM 16 CENTRES IN THE USA AND EUROPE ARE ENROLLED INTO A PROSPECTIVE 10-YEAR OUTCOME STUDY. A TOTAL OF 839 PATIENTS HAD PRE- AND POSTOPERATIVE PELVIC AP RADIOGRAPHS, AND WERE INCLUDED IN THIS STUDY. PRESENCE OF AD, DEFINED AS LCE ANGLE >25 DEG, IS AN INDEPENDENT RISK FACTOR FOR MALPOSITION OF THE ACETABULAR COMPONENT DURING PRIMARY THA. SKIN APPROACH AND RADIOLOGICAL GRADE OF OA WERE ALSO INDEPENDENTLY CORRELATED TO MALPOSITIONED CUPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754458 UNKNOWN HIP PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention