BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP CNV GLEN LINER IMPACTOR

    MDR report key: 5136672 · Received October 8, 2015

    Report

    Report Number
    0001825034-2015-04229
    Event Type
    Injury
    Date Received
    October 8, 2015
    Date of Event
    September 8, 2015
    Report Date
    November 9, 2015
    Manufacturer
    BIOMET SET
    Product Code
    KWS
    PMA / PMN Number
    PK130390
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. DEVICE AVAILABILITY - THE DEVICE IS REPORTED TO BE AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED BY BIOMET ORTHOPEDICS TO DATE. IN THE EVENT THAT THE DEVICE IS RECEIVED AND EVALUATED, A FOLLOW UP REPORT WILL BE SENT TO THE FDA TO PROVIDE RESULTS. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER PRECAUTIONS, IT STATES, ¿INTRAOPERATIVE FRACTURE OR BREAKING OF INSTRUMENTS HAS BEEN REPORTED FOR GENERAL INSTRUMENTS.¿

    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. PRODUCT LEFT CONFORMING TO PRINT AS THERE WAS NO EVIDENCE THAT STATES OTHERWISE. VISUAL REVIEW SHOWS THE SIDE OF THE IMPACTOR HEAD FRACTURED AND FRACTURED OFF. INSTRUMENT FRACTURE MOST LIKELY OCCURRED DUE TO INCORRECT ALIGNMENT. BASED ON THESE RESULTS THE COMPLAINT IS CONSIDERED CONFIRMED.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2015. DURING THE PROCEDURE, THE GLENOID POLY IMPACTOR FRACTURED WHILE INSERTING THE POLY. A PIECE FELL INTO THE PATIENT AND WAS RETRIEVED. ANOTHER POLY IMPACTOR WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665508 COMP CNV GLEN LINER IMPACTOR PROSTHESIS, SHOULDER KWS BIOMET SET N/A 632310

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention