BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTICULEZE M HEAD 36MM +8.5

    MDR report key: 2093721 · Received May 12, 2011

    Report

    Report Number
    1818910-2011-08241
    Event Type
    Malfunction
    Date Received
    May 12, 2011
    Date of Event
    January 7, 2006
    Report Date
    April 12, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    JDI
    PMA / PMN Number
    K980513
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    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.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED AND ARE PRESUMED YET IMPLANTED. 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 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 THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: 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. 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

    LITIGATION PAPERS ALLEGE THE FOLLOWING: FOR THE FIRST FEW MONTHS, PT'S HIP IMPLANT DID WELL. BUT IN (B)(6) 2005 SHE BEGAN TO NOTICE PAIN AND NUMBNESS IN HER HIP AND GROIN AREA. HER DOCTOR PRESCRIBED ADD'L PHYSICAL THERAPY WHICH DID NOT SIGNIFICANTLY IMPROVE HER SYMPTOMS AND ON (B)(6) 2006, PT'S RIGHT HIP DISLOCATED FROM THE SOCKET. AFTER FIRST ATTEMPTING TO REDUCE THE DISLOCATION WITHOUT AN OPEN INCISION, HER DOCTOR DECIDED THAT PT NEEDED TO HAVE HER HIP IMPLANT SURGICALLY REMOVED AND REPLACED AS SOON AS POSSIBLE. DURING THE REVISION SURGERY, THE SURGEON FOUND THAT THE ACETABULAR CUP IN PT'S HIP IMPLANT "WAS COMPLETELY LOOSE." DURING THE SURGERY, SURGEON ALSO FOUND "TURBID MATERIAL COMING OUT OF PT'S RIGHT HIP JOINT. SURGEON ALSO NOTED THAT PT HAS "MULTIPLE PELVIC FRACTURES AND A LOOSE ACETABULUM IN THE ABSENCE OF ANY RECORDED TRAUMA."

    Description of Event or Problem · 1

    PPF ALLEGES DISLOCATION WITH OPEN REDUCTION, LOOSENING OF THE CUP, AND FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTICULEZE M HEAD 36MM +8.5 ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS JDI DEPUY ORTHOPAEDICS, INC. 1818910 NA 1110522

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention