BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LRE RAD HD 5CM MED BRGS

    MDR report key: 3756412 · Received April 17, 2014

    Report

    Report Number
    0001825034-2014-02913
    Event Type
    Injury
    Date Received
    April 17, 2014
    Date of Event
    May 20, 2014
    Report Date
    November 10, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWI
    PMA / PMN Number
    PNONE FOUND
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE AND A REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY. THEREFORE IT IS DETERMINED THAT PRODUCT LEFT BIOMET CONFORMING. MATERIAL ANALYSIS OF THE DEVICE FOUND PATCHES OF ABRASIVE WEAR WHICH SUGGESTS POSSIBLE RADIAL SUBLUXATION.

    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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON NOVEMBER 10, 2014 INDICATING THAT THE CAUSE OF THE EVENT WAS LOOSENING OF THE CAPITELLAR COMPONENT. THIS COMPONENT IS NOT MANUFACTURED OR MARKETED IN THE U.S. SO THIS MEDWATCH WOULD NOT BE REPORTABLE.

    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. 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.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A LEFT CUSTOM ELBOW ARTHROPLASTY ON (B)(6) 2013. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2014 DUE TO PAIN, LACK OF MOBILITY, ULNAR NERVE COMPRESSION AND INSTABILITY. IT WAS FURTHER NOTED THE CAPITELLAR COMPONENT HAD LOOSENED. THE CAPITELLAR COMPONENT WAS REMOVED AND REPLACED. REVIEW OF INVOICE HISTORY CONFIRMED THE INITIAL PROCEDURE DATE AND THAT A RADIAL HEAD WAS IMPLANTED; HOWEVER, IT COULD NOT CONFIRM IF A BIOMET CAPITELLER COMPONENT WAS UTILIZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A CUSTOM ELBOW PROCEDURE ON (B)(6) 2013. SUBSEQUENTLY, ANOTHER REVISION PROCEDURE HAS BEEN INDICATED FOR AN UNKNOWN REASON, BUT THERE HAS BEEN NO REPORTED REVISION TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A LEFT CUSTOM ELBOW ARTHROPLASTY ON (B)(6) 2013. SUBSEQUENTLY, A REVISION PROCEDURE HAS BEEN SCHEDULED DUE TO PAIN, LACK OF MOBILITY, ULNAR NERVE COMPRESSION AND INSTABILITY; HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234393 LRE RAD HD 5CM MED BRGS PROSTHESIS, ELBOW KWI BIOMET ORTHOPEDICS N/A 318360

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R