BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS RS 7 CM MOD SEG FMRL-LT

    MDR report key: 4019740 · Received August 19, 2014

    Report

    Report Number
    0001825034-2014-07068
    Event Type
    Injury
    Date Received
    August 19, 2014
    Date of Event
    July 21, 2014
    Report Date
    October 17, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KRO
    PMA / PMN Number
    PK021260
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. (B)(4).

    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. 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. CORRECTED DATA: CORRECT PRODUCT CODE IS KRO.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2011 UTILIZING AN ORTHOPEDIC SALVAGE SYSTEM. SUBSEQUENTLY, THE PATIENT REQUIRED LEG LENGTHENING AND UNDERWENT A REVISION PROCEDURE ON (B)(6) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT HIP ARTHROPLASTY ON AN UNKNOWN DATE IMPLANTING AN ORTHOPEDIC SALVAGE SYSTEM. SUBSEQUENTLY, A REVISION HAS BEEN INDICATED DUE TO THE IMPLANT NEEDING TO BE LENGTHENED; HOWEVER, NO REVISION HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497134 OSS RS 7 CM MOD SEG FMRL-LT REDUCED SIZE ONCOLOGY SALVAGE SYSTEM KRO BIOMET ORTHOPEDICS N/A 942020

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention