BEUDAMED
    FDA Adverse Event Injury Summary report: N

    14/16 LG TAPER M HEAD 36MM+11

    MDR report key: 3242207 · Received July 23, 2013

    Report

    Report Number
    1818910-2013-21877
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    April 1, 2010
    Report Date
    June 28, 2013
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK120599
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LOT CODES REQUIRED WERE NOT PROVIDED. PER THE INITIAL REPORTING BY THE DEPUY CLINICAL TEAM, NO ADDITIONAL INFORMATION IS AVAILABLE. 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. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    CLINICAL REPORT STATES THE PATIENT HAD A LINER AND HEAD EXCHANGE FOR DISLOCATION OF A CONSTRAINED LINER 0.5 YEARS AFTER SURGERY. THE PATIENT HAD THEIR FIRST REVISION AT THE (B)(6) CONSISTING OF A LINER AND HEAD EXCHANGE FOR RECURRENT DISLOCATION USING A CONSTRAINED LINER 2.9 YEARS PRIOR TO THE CURRENT EVENT. SURGERY PRIOR TO THIS INITIAL REVISION WAS PERFORMED AT AN OUTSIDE INSTITUTION. THE PATIENT DISLOCATED FROM THEIR CONSTRAINED LINER AND UNDERWENT AN OPEN REDUCTION WITH A HEAD EXCHANGE AND PLACEMENT OF ANOTHER CONSTRAINED LINER 2.4 YEARS AFTER THEIR INITIAL REVISION AT THE (B)(6). THE PATIENT DISLOCATED AGAIN AS NOTED IN THE PRECEDING RECORD AND WAS CONVERTED TO A TRIPOLAR CONSTRUCT USING A BIPOLAR HEAD COMBINED WITH A LINER EXCHANGE DURING THE CURRENT REVISION 33 DAYS AFTER THE MOST RECENT DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342973 14/16 LG TAPER M HEAD 36MM+11 HEAD LPH 1818910 DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention