BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTAMET MTL INS NEUT 28MM 50OD

    MDR report key: 3253976 · Received July 30, 2013

    Report

    Report Number
    1818910-2013-22459
    Event Type
    Injury
    Date Received
    July 30, 2013
    Date of Event
    July 19, 2013
    Report Date
    August 27, 2013
    Manufacturer
    DEPUY INTERNATIONAL LTD. ¿ REG. # 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK073504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE INVESTIGATION HAS BEEN REOPENED DUE TO RECEIVING ADDITIONAL INFORMATION. DEPUY WILL NOTIFY THE FDA WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED DEVICES CONFIRMS THE PRESENCE OF MINIMAL TRIBOLOGICAL MATTER ON BOTH MALE AND FEMALE TAPERS. BOTH MALE AND FEMALE TAPERS AND IN RELATIVELY GOOD CONDITION. ADDITIONAL EVENT INFORMATION WAS REQUESTED BUT NOT PROVIDED. HEAVY DAMAGE, LIKELY FROM EXTRACTION, IS NOTED ON THE HEAD, STEM, AND INSERT. ABNORMAL WEAR IS NOT FOUND ON THE ARTICULATING SURFACES OF THE FEMORAL HEAD AND INSERT DURING THE VISUAL EVALUATION. PATIENT X-RAYS WERE NOT MADE AVAILABLE TO CONFIRM LOOSENING, HOWEVER, IT WAS INITIALLY REPORTED THE IMPLANTS WERE FOUND TO HAVE LOOSENED DUE TO ACETABULAR AND FEMORAL OSTEOLYSIS. IT WAS ALSO REPORTED THE ACETABULAR CUP REMAINS IMPLANTED IN THE PATIENT AND WAS FOUND TO HAVE BEEN FIRMLY FIXED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PROVIDED PRODUCT/LOT CODE COMBINATIONS. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION WAS COMPLETED BY APPLIED RESEARCH AND BIOENGINEERING, WITH A REPORT RECEIVED 12-JUNE-14, CONCLUDING: ROOT CAUSE: UNDETERMINED. BASED ON THE INFORMATION RECEIVED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE NEED FOR REVISION WAS UNDETERMINED. THE CUSTOMER DID NOT REPORT A DEVICE DEFECT. IT IS UNLIKELY THAT THERE WAS A MANUFACTURING FAULT. THE COMPLAINT SHALL NOW BE CLOSED WITH AN UNDETERMINED CONCLUSION; IT SHALL BE ENTERED ONTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. SHOULD FURTHER INFORMATION BE RECEIVED, THEN THE COMPLAINT SHALL BE INVESTIGATED FURTHER.

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE SURGEON, THE IMPLANTS WERE FOUND LOOSENED DUE TO OSTEOLYSIS AROUND THE ACETABULUM AND FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356368 ULTAMET MTL INS NEUT 28MM 50OD METAL ACETABULAR INSERT KWA DEPUY INTERNATIONAL LTD. ¿ REG. # 8010379 2300032

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention