BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DLT TS CER HD 12/14 36MM +5.0

    MDR report key: 4241604 · Received November 10, 2014

    Report

    Report Number
    1818910-2014-31468
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 16, 2014
    Report Date
    January 23, 2015
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    KWA
    PMA / PMN Number
    PK073504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT/LOT COMBINATIONS SINCE RELEASE FOR DISTRIBUTION. 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. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. 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. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS SUSPECTED INFECTION.

    Description of Event or Problem · 1

    PFS AND MEDICAL RECORDS RECEIVED. THIS COMPLAINT IS NOW LEGAL. LITIGATION ALLEGES INFECTION. REVISION OPERATIVE NOTE NOT INCLUDED AT THIS TIME TO CONFIRM INFECTION.

    Description of Event or Problem · 1

    PPF HAS NO NEW ALLEGATIONS REPORTED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS RIGHT HIP WOUND INFECTION. REVISION FINDINGS STATED, PURULENCE THAT TRACKED ALL THE WAY DOWN TO THE HIP JOINT. SOFT TISSUES APPEARED SOMEWHAT FRIABLE AND INFLAMED WITH VASCULAR FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722184 DLT TS CER HD 12/14 36MM +5.0 HIP FEMORAL HEAD KWA DEPUY IRELAND - 9616671 7830687

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other| R