BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SHOULDER

    MDR report key: 4170835 · Received October 14, 2014

    Report

    Report Number
    0001825034-2014-08036
    Event Type
    Injury
    Date Received
    October 14, 2014
    Report Date
    October 14, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 S. ALEXANDER AND A. WALLACE; J BONE JOINT SURG BR 2005 VOL. 87-B NO. SUPP III 332; 510K NUMBER - UNKNOWN; MANUFACTURE DATE ¿ UNKNOWN.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "ARTHROSCOPIC CAPSULOLABRAL RECONSTRUCTION USING THE KNOTLESS SUTURE ANCHOR ¿ A TWO-YEAR FOLLOW-UP,¿ WHICH FOLLOWED ONE HUNDRED AND NINE (109) PATIENTS. THE ARTICLE CONCLUDED THAT ARTHROSCOPIC CAPSULOLABRAL RECONSTRUCTION, WITH AN AVERAGE OF THREE ANCHORS USED PER CASE, WAS AN EFFECTIVE ALTERNATIVE TO OPEN SURGERY. THIS STUDY WAS CONDUCTED OVER A PERIOD OF TWO (2) YEARS POST-OP AND REPORTS THE RESULTS OBTAINED. THE JOURNAL ARTICLE REPORTS AFTER TWO (2) YEARS POST-OP, THREE PATIENTS HAVE HAD SINGLE EPISODES OF SUBLUXATION BUT HAVE NOT REQUIRED REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648931 UNKNOWN SHOULDER PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R