BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 4840256 · Received June 12, 2015

    Report

    Report Number
    3002806535-2015-00256
    Event Type
    Injury
    Date Received
    June 12, 2015
    Date of Event
    June 6, 2015
    Report Date
    August 26, 2015
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JWH
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RETURNED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. (B)(4) - PRODUCT IS EXPECTED TO BE RETURNED. UPON RECEIPT OF PRODUCT AND EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION AND PRODUCT EVALUATION RESULTS, WHICH WERE NOT KNOWN AT THE TIME OF THE INITIAL MEDWATCH. EXAMINATION OF RETURNED DEVICE WAS INCONCLUSIVE. DURING THE EVALUATION, IT WAS NOTED THAT THERE WAS EVIDENCE OF NORMAL WEAR AND TEAR AND THE DEVICE WAS LIKELY AT THE END OF ITS USEFUL LIFE; HOWEVER, ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT ON (B)(6) 2015. DURING THE PROCEDURE THE HEAD OF THE TIBIAL PREP PIN FRACTURED CAUSING THE DISTAL SECTION OF THE NAIL TO BE RETAINED BY THE PATIENT. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386553 UNKNOWN PROTHESIS, KNEE JWH BIOMET UK LTD. N/A ZB090119

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability