BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +5

    MDR report key: 2312381 · Received October 28, 2011

    Report

    Report Number
    1818910-2011-21824
    Event Type
    Injury
    Date Received
    October 28, 2011
    Date of Event
    October 28, 2009
    Report Date
    December 21, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    PK980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS 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. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION IS ONGOING. 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. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL REPORTS FOR THE LOT CODES YC3FB1, 1092398, AND XR9DA1. A SEARCH OF THE COMPLAINT DATABASE SEARCH FINDS ONE ADDITIONAL REPORTED INCIDENT AGAINST LOT CODE 1158115 SINCE ITS RELEASE FOR DISTRIBUTION; HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES IDENTIFIED OTHER REPORTS AGAINST THE LINER. PER PROCEDURE, THIS DEVICE IS EXEMPT FROM DEVICE HISTORY RECORD REVIEW. ONE OTHER REPORT WAS FOUND AGAINST THE 1158115 LOT CODE. DEVICE HISTORY RECORDS WERE PREVIOUSLY REVIEWED WITH NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES NOTED. THE SEARCH IDENTIFIED NO OTHER REPORTS AGAINST THE REMAINING PRODUCT/LOT CODE COMBINATIONS. XRAYS WERE REVIEWED. 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). (B)(4) USED TO CAPTURE MEDICAL DEVICE REMOVAL.

    Description of Event or Problem · 1

    UPDATE 2/25/16 - MEDICAL RECORDS RECEIVED. MEDICAL RECORDS REVIEWED FOR MDR REPORTABILITY. MEDICAL RECORDS REPORTED HETEROTOPIC OSSIFICATION, NUMBNESS AND TINGLING AND DEEP TENDON REFLEXES ABSENT AT KNEES AND ANKLES WITH SIGNIFICANT RADICULOPATHY OF THE RIGHT LOWER EXTREMITY STATUS POST L-5 DECOMPRESSION FOR LEFT LEG PAIN. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING INVESTIGATION. THE COMPLAINT WAS UPDATED ON: MAR 9, 2016.

    Description of Event or Problem · 1

    PPF ALLEGES LOOSENING OF CUP.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: ON OR ABOUT (B)(6), 2006, BILATERAL PATIENT WAS IMPLANTED WITH A DEPUY PINNACLE MOM HIP IMPLANT ON HIS RIGHT SIDE (LEFT SIDE WAS ENTERED IN A SEPARATE COMPLAINT). FOLLOWING THE SURGERY, PATIENT SUFFERED FROM SEVERE PAIN AND DISCOMFORT, AND MECHANICAL LOOSENING AND COMPLICATIONS OF HIS RIGHT TOTAL HIP ARTHROPLASTY. ON (B)(6), 2009, PATIENT WAS REVISED ON HIS RIGHT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTICULEZE M HEAD 36MM +5 FEMORAL HEAD JDI DEPUY ORTHOPAEDICS INC US 2107753

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention