BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-MOD 48X24MM HEAD 4MM OFFSET

    MDR report key: 4251499 · Received November 14, 2014

    Report

    Report Number
    0001825034-2014-08624
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 21, 2014
    Report Date
    January 14, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PK992899
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CORRECTED TO INDICATE THAT THE INITIAL SHOULDER PROCEDURE WAS A HEMI-ARTHROPLASTY AND NOT A TOTAL SHOULDER REPLACEMENT.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY INFORMATION WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    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. CATALOG NUMBER, LOT NUMBER AND EXPIRATION DATE - UNKNOWN. DATE IMPLANTED - UNKNOWN. 510K NUMBER - UNKNOWN. MANUFACTURE DATE ¿ UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT WAS REVISED TO A COMPREHENSIVE REVERSE SHOULDER SYSTEM ON (B)(6) 2014 DUE TO UNKNOWN REASONS. DURING THE PROCEDURE, THE SURGEON CUT OFF THE PIN FROM THE HUMERAL STEM AS IT WAS INTERFERING WITH THE SEATING OF THE HUMERAL TRAY. THERE WERE NO COMPLICATIONS, NO DELAY AND NO PATIENT INJURY AS A RESULT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A SHOULDER HEMI-ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, PATIENT WAS REVISED TO A REVERSE SHOULDER SYSTEM ON (B)(6)2014 DUE TO IMPINGEMENT. DURING THE PROCEDURE, THE SURGEON CUT OFF THE PIN FROM THE HUMERAL STEM AS IT WAS INTERFERING WITH THE SEATING OF THE HUMERAL TRAY. THERE WERE NO COMPLICATIONS, NO DELAY AND NO PATIENT INJURY AS A RESULT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT WAS REVISED TO A COMPREHENSIVE REVERSE SHOULDER SYSTEM ON (B)(6) 2014 DUE TO IMPINGEMENT. DURING THE PROCEDURE, THE SURGEON CUT OFF THE PIN FROM THE HUMERAL STEM AS IT WAS INTERFERING WITH THE SEATING OF THE HUMERAL TRAY. THERE WERE NO COMPLICATIONS, NO DELAY AND NO PATIENT INJURY AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737661 BIO-MOD 48X24MM HEAD 4MM OFFSET PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A 431370

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R