BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 4214123 · Received October 30, 2014

    Report

    Report Number
    0001825034-2014-08242
    Event Type
    Injury
    Date Received
    October 30, 2014
    Report Date
    October 2, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PUNK
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT CONCLUSIONS AS TO THE CAUSE OF THE EVENTS. EVENT DETAILS AND PRODUCT IDENTIFICATION WAS NOT PROVIDED FOR THE PATIENTS MENTIONED IN THE JOURNAL ARTICLE. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT - UNKNOWN. EXPIRATION DATE - UNKNOWN. DATE IMPLANTED - UNKNOWN. DATE EXPLANTED - UNKNOWN. INITIAL REPORTER - THE ARTICLE WAS WRITTEN BY M. VAN HEUMEN, P. J. C. HEESTERBEEK, B. A. SWIERSTRA, G. G. VAN HELLEMONDT, AND J. H. M. GOOSEN. J ORTHOPAED TRAUMATOL, DOI 10.1007/S10195-014-0318-7. MANUFACTURE DATE ¿ UNKNOWN.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "DUAL MOBILITY ACETABULAR COMPONENT IN REVISION TOTAL HIP ARTHROPLASTY FOR PERSISTENT DISLOCATION: NO DISLOCATIONS IN 50 HIPS (49 PATIENTS, 10 MALE & 39 FEMALE) AFTER 1-5 YEARS¿ WHICH PROPOSED THAT DUAL MOBILITY CUPS HAVE THE THEORETIC POTENTIAL TO IMPROVE STABILITY IN PRIMARY TOTAL HIP ARTHROPLASTY (THA) AND MID-TERM COHORT RESULTS ARE FAVORABLE. THIS STUDY FOLLOWED FORTY-NINE PATIENTS (FIFTY HIPS) WHO RECEIVED AN ISOLATED ACETABULAR REVISION WITH A DUAL MOBILITY CUP BETWEEN JANUARY 2007 AND JUNE 2011. THE JOURNAL ARTICLE REPORTS THAT RE-REVISIONS AND/OR ADVERSE EVENTS OCCURRED DUE TO THE FOLLOWING REASONS: TWO (2) REVISIONS DUE TO INFECTION. TWO (2) IRRIGATION AND DEBRIDEMENT PROCEDURES; NO IMPLANTS REMOVED. ONE (1) REVISION ON THE SAME DAY AN UNDERSIZED CUP WAS IMPLANTED AND FOUND TO BE LOOSE. ONE (1) REVISION DUE TO SCIATIC NERVE PALSY. THE ARTICLE CONCLUDED THAT THE SURVIVAL AFTER 56 MONTHS WAS 100% BASED ON DISLOCATION AND 93% BASED ON RE-REVISION FOR ANY REASON. THE DUAL MOBILITY CUP IS AN EFFICIENT SOLUTION FOR INSTABILITY OF THA WITH A FAVORABLE IMPLANT SURVIVAL AT 56 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694959 UNKNOWN PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A UKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R