BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VANGUARD CR KNEE

    MDR report key: 4170792 · Received October 14, 2014

    Report

    Report Number
    0001825034-2014-08035
    Event Type
    Injury
    Date Received
    October 14, 2014
    Report Date
    September 16, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    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; BRAND NAME - UNKNOWN; CATALOG NUMBER, LOT NUMBER AND EXPIRATION DATE - UNKNOWN; DATE IMPLANTED - UNKNOWN; DATE EXPLANTED - UNKNOWN; INITIAL REPORTER - THE ARTICLE WAS WRITTEN BY DAE KYUNG BAE, SANG JUN SONG, KYOUNG HO YOON, JUNG HO NOH AND SEONG CHEOL MOON; INTERNATIONAL ORTHOPAEDICS (SICOT) (2012) 36:755¿760 DOI 10.1007/S00264-011-1395-3. G5 - 510K NUMBER - UNKNOWN H4 - MANUFACTURE DATE ¿ UNKNOWN

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "COMPARATIVE STUDY OF TIBIAL POSTERIOR SLOPE ANGLE FOLLOWING CRUCIATE-RETAINING TOTAL KNEE ARTHROPLASTY USING ONE OF THREE IMPLANTS¿ WHICH COMPARED PRE AND POST-OPERATIVE POSTERIOR SLOPE ANGLE (PSA) IN THREE GROUPS OF PATIENTS. THE STUDY WAS CONDUCTED OVER A PERIOD OF SIX YEARS (2003-2009) AND INVOLVED THREE HUNDRED EIGHTY SIX CRUCIATE RETAINING TKAS IN THREE HUNDRED EIGHT (308) PATIENTS . GROUPS ONE AND TWO CONSISTED OF THREE HUNDRED TWENTY-TWO (322) CASES THAT INVOLVED COMPETITOR KNEE SYSTEMS. GROUP THREE CONSISTED OF SIXTY-FOUR (64) CASES INVOLVING BIOMET VANGUARD CR KNEES. THE JOURNAL ARTICLE REPORTS THAT POSTOPERATIVE COMPLICATIONS OCCURRED IN TWO KNEES; PATELLAR SUBLUXATION OCCURRED IN ONE KNEE AND DEEP INFECTION DEVELOPED IN THE OTHER. THE PATIENT WITH PATELLAR SUBLUXATION REFUSED FURTHER OPERATIVE TREATMENT. THE CASE OF DEEP INFECTION (ACUTE HAEMATOGENOUS PATTERN AT 2.5 YEARS) OCCURRED IN A PATIENT IN GROUP 3 AND WAS TREATED SUCCESSFULLY BY TWO-STAGE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649439 UNKNOWN VANGUARD CR KNEE PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R