BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP

    MDR report key: 3781503 · Received April 30, 2014

    Report

    Report Number
    0001825034-2014-03439
    Event Type
    Injury
    Date Received
    April 30, 2014
    Report Date
    April 2, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED: EVENT DATE - 1993, EXACT DATE IS UNKNOWN, PRODUCT IDENTIFICATION/EXPIRY DATE, DATE EXPLANTED - 1993, EXACT DATE IS UNKNOWN, MANUFACTURE DATE. THIS REPORT IS NUMBER 3 OF 4 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-00823/00824 & 03439/03440).

    Description of Event or Problem · 1

    BIOMET ORTHOPEDICS RECEIVED PRELIMINARY CLINICAL DATA REGARDING PATIENTS ENROLLED IN A CLINICAL STUDY. IT WAS REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2009 DUE TO AN UNKNOWN REASON. THE MODULAR HEAD WAS REMOVED AND REPLACED. IT WAS REPORTED THAT PATIENT UNDERWENT FURTHER REVISION ON (B)(6) 2009 DUE TO INFECTION. THE MODULAR HEAD, ACETABULAR CUP AND LINER WERE REMOVED AND REPLACED. IT HAS BEEN REPORTED THAT THE PATIENT UNDERWENT FOUR ADDITIONAL SURGERIES PRIOR TO THE (B)(6) 2009 REVISION. ADDITIONAL INFORMATION RECEIVED IN PATIENT CLINICAL DATA INDICATES THAT PATIENT UNDERWENT INITIAL LEFT TOTAL HIP ARTHROPLASTY IN 1973 RECEIVING A COMPETITOR¿S HIP. A SUBSEQUENT REVISION PROCEDURE WHERE PATIENT WAS IMPLANTED WITH BIOMET FEMORAL COMPONENTS OCCURRED ON (B)(6) 1991 FOR AN UNKNOWN REASON. CLINICAL DATA INDICATES THAT ANOTHER REVISION PROCEDURE TOOK PLACE IN 1993 FOR AN UNKNOWN REASON. PATIENT OPERATIVE NOTES CONFIRMED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2008 DUE TO ACETABULAR CUP LOOSENING, WEAR OF THE POLYETHYLENE ACETABULAR LINER AND TITANIUM DEBRIS. PATIENT MEDICAL RECORDS FURTHER CONFIRM THAT A REVISION PROCEDURE TOOK PLACE ON (B)(6) 2009 DUE TO INFECTION. A RADICAL DEBRIDEMENT WAS PERFORMED DURING THIS REVISION PROCEDURE AND THE ACETABULAR CUP WAS REMOVED AND REPLACED WITH A CEMENT SPACER MOLD. REVISION OPERATIVE NOTES FROM (B)(6) 2009 CONFIRM THAT THIS REVISION WAS PERFORMED DUE TO INFECTION. THE ACETABULAR CEMENT SPACER MOLD WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260952 UNKNOWN HIP PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R