BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN MAR NEUT 28IDX48OD

    MDR report key: 3222405 · Received July 12, 2013

    Report

    Report Number
    1818910-2013-21021
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    May 11, 2015
    Report Date
    March 6, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    PK001534
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE AND/OR DHR REVIEW 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 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

    THE 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

    (B)(4). THE INVESTIGATION HAS BEEN REOPENED DUE TO RECEIVING REVISION INFORMATION. DEPUY WILL NOTIFY THE FDA WHEN THE INVESTIGATION IS COMPLETE. (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). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE ITS RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR 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

    UPDATE RECEIVED (B)(6) 2015. THE SALES REP HAS REPORTED THE REVISION. PATIENT WAS REVISED TO ADDRESS PAIN. REPORT ALSO NOTES THAT THE FEMORAL HEAD IS OFF CENTER INDICATING WEAR OF THE POLY LINER. INTRAOPERATIVELY, THE SURGEON STATED THAT THE CUP WAS TOO VERTICAL. THE CUP IS NO BEING REPORT TO THE COMPLAINT.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PAIN AND DIFFICULTY AMBULATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321992 PINN MAR NEUT 28IDX48OD HIP LINER LPH DEPUY ORTHOPAEDICS INC US ZD6FK1000

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other