BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM DIA COCR MOD HEAD +9MM NK

    MDR report key: 2993818 · Received March 8, 2013

    Report

    Report Number
    0001825034-2013-00517
    Event Type
    Injury
    Date Received
    March 8, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 14, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK911684
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND WEAR THAT IS CONSISTENT WITH IMPINGEMENT BETWEEN THE LINER AND THE TRUNNION OF THE STEM. THE CRACKED AND BRITTLE APPEARANCE OF THESE TWO REGIONS SUGGESTS THAT THE MATERIAL MAY HAVE OXIDIZED IN THE PATIENT. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00517-1 / 00518-1).

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS. WEAR AND/OR DEFORMATION OF ARTICULATING SURFACES. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 1999. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2013 DUE TO DISLOCATION AND CLICKING DUE TO POLY WEAR. THE FEMORAL HEAD AND POLY LINER COMPONENENTS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99680 28MM DIA COCR MOD HEAD +9MM NK PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 574610

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R