BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN LNR CON +4 NEUT 32IDX52OD

    MDR report key: 3201778 · Received July 2, 2013

    Report

    Report Number
    1818910-2013-20367
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    December 6, 2012
    Report Date
    June 3, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    KWZ
    PMA / PMN Number
    PK043058
    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. (B)(4).

    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. MEDICAL RECORDS WERE OBTAINED. MEDICAL RECORDS INDICATE PATIENT WAS REVISED DUE TO RECURRENT DISLOCATION. THERE WAS SOME METALLIC STAINING THAT WAS CLEANED UP OFF THE ACETABULUM. DOI: (B)(6) 2012 - DOR: (B)(6) 2012. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES REQUIRED WERE NOT PROVIDED. THE ONLY AVAILABLE MEDICAL RECORD IS THAT OF THE REVISION OPERATIVE REPORT DATED (B)(6) 2012. THE PREOPERATIVE DIAGNOSIS WAS RECURRENT DISLOCATION OF THE RIGHT HIP AND THE SURGEON DIRECTLY VISUALIZED THE HEAD THAT WAS DISLOCATED POSTERIORLY. THE SURGEON REVISED BOTH THE HEAD COMPONENT AND PLACED THE LINER WITH A CONSTRAINED CUP COMPONENT. THERE ARE NO OTHER RECORDS, HISTORY AND PHYSICAL OR PHYSICIAN PROGRESS NOTES PRIOR TO OR FOLLOWING THIS PROCEDURE. THERE IS A NOTE THAT AFTER THE INCISION WAS MADE THERE WAS SOME "YELLOWISH" FLUID THAT WAS REMOVED AND CULTURED BUT THOSE CULTURES ARE NOT AVAILABLE FOR REVIEW EITHER. FROM A MEDICAL PERSPECTIVE, BASED ON THE INFORMATION AVAILABLE, IT IS NOT POSSIBLE TO DETERMINE IF THE COMPLAINT IS PRODUCT RELATED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR 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

    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

    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.DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    MEDICAL RECORDS WERE OBTAINED. MEDICAL RECORDS INDICATE PATIENT WAS REVISED DUE TO RECURRENT DISLOCATION. THERE WAS SOME METALLIC STAINING THAT WAS CLEANED UP OFF THE ACETABULUM.

    Description of Event or Problem · 1

    UPDATE 4-24-15-PFS AND MEDICAL RECORDS RECEIVED. A CORRECT DOI WAS PROVIDED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE INDICATED DISLOCATION. PART/LOT IS BEING UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301854 PINN LNR CON +4 NEUT 32IDX52OD LINER KWZ DEPUY ORTHOPAEDICS, INC. 1818910 140944

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention