BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD PKS FEMORAL COCR MEDIUM

    MDR report key: 3251664 · Received July 29, 2013

    Report

    Report Number
    3002806535-2013-00146
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    June 27, 2013
    Report Date
    July 1, 2013
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    PP010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO PRODUCT HAS BEEN RETURNED TO DATE. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. EXPIRATION DATE - UNKNOWN. IMPLANT - ABOUT A YEAR AGO (EXACT DATE UNKNOWN). MANUFACTURE DATE - UNKNOWN. ITEM HAS BEEN REQUESTED TO BE RETURNED. UPON RECEIPT AND PRODUCT EVALUATION, A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION WAS RECEIVED ON (B)(4) 2013 INDICATING THAT THE SURGEON DID NOT APPROVE FOR RETURN OF DEVICE. NO INVESTIGATION CAN BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PRIMARY KNEE SURGERY ABOUT A YEAR AGO. REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013 DUE TO PAIN. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352224 OXFORD PKS FEMORAL COCR MEDIUM OXFORD FEMORAL KNEE NRA BIOMET UK LTD. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R