BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIDENTIFIED INSERT

    MDR report key: 3972634 · Received August 1, 2014

    Report

    Report Number
    1818910-2014-24495
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 15, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A REVIEW OF COMPLAINTS DATABASE AND MANUFACTURING RECORDS DID NOT IDENTIFY ANY ANOMALIES. BASED ON THE INFORMATION RECEIVED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE COMPLAINT WAS UNDETERMINED. THE CUSTOMER DID NOT REPORT A DEVICE DEFECT. IT IS NOT POSSIBLE TO DETERMINE IF THERE WAS A MANUFACTURING FAULT. NO CORRECTIVE ACTION IS REQUIRED. POST MARKET SURVEILLANCE IS PER SEP-419. NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. CORRECTIVE ACTION WAS NOT INDICATED. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION; IT WILL BE ENTERED INTO THE COMPLAINT DATABASE AND MONITORED THROUGH TREND ANALYSIS.

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION WAS RECEIVED, ACCORDING TO THE PART/LOT INFORMATION THIS PRODUCT IS NOT SOLD IN THE US.IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    PLANNED REVISION ON (B)(6) 2014 OF HIP TEP BECAUSE OF SUSPECTED FRACTURE OF CERAMIC INLAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450276 UNIDENTIFIED INSERT HIP ACETABULAR INSERT/LINER KWY DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention