BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 2071513 · Received April 15, 2011

    Report

    Report Number
    1818910-2011-06655
    Event Type
    Injury
    Date Received
    April 15, 2011
    Report Date
    October 7, 2013
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    CORRECTED: EVENT/PROBLEM DESCRIPTION, BRAND NAME, COMMON DEVICE NAME, CATALOG #/LOT #, IMPLANT DATE, EXPLANT DATE, PMA/510(K) #, MANUFACTURE DATE. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    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

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: FOLLOWING HIS SURGERY, PATIENT BEGAN SUFFERING FROM DISCOMFORT AND PAIN IN HIS HIP. HE ALSO EXPERIENCED LOOSENING OF HIS HIP. IN (B)(6) 2010, PATIENT UNDERWENT SURGERY FOR REVISION OF THE PROSTHETIC FEMORAL HEAD ONLY. HOWEVER, HE CONTINUES TO EXPERIENCE LOOSENING OF HIS HIP, CONTINUES TO SUFFER SEVERE PAIN AND WALKS WITH A LIMP. HE HAS BEEN PRESCRIBED PAIN MEDICATION BY HIS PHYSICIAN AND USES A CANE FOR WALKING.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: FOLLOWING HIS SURGERY, PATIENT BEGAN SUFFERING FROM DISCOMFORT AND PAIN IN HIS HIP. HE ALSO EXPERIENCED LOOSENING OF HIS HIP. IN (B)(6) 2010, PATIENT UNDERWENT SURGERY FOR REVISION OF THE PROSTHETIC FEMORAL HEAD ONLY. HOWEVER, HE CONTINUES TO EXPERIENCE LOOSENING OF HIS HIP, CONTINUES TO SUFFER SEVERE PAIN AND WALKS WITH A LIMP. HE HAS BEEN PRESCRIBED PAIN MEDICATION BY HIS PHYSICIAN AND USES A CANE FOR WALKING. UPDATE: (B)(4) 2011 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION, DATE OF IMPLANT, DATE OF REVISION AND SIDE. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Description of Event or Problem · 1

    **UPDATE** - MEDICAL RECORDS RECEIVED (B)(4)2013. REVISION OPERATIVE REPORT INDICATES THE FOLLOWING: MASSIVE SEROMA; DISCOMFORT; SEROUS FLUID THAT IS SOMEWHAT CLOUDY; PARTIAL BREAKDOWN OF THE ANTERIOR REPAIR; EXTENSIVE FOREIGN BODY REACTION AND PSEUDOMEMBRANOUS FORMATION THROUGHOUT WITH SOFT TISSUE DEBRIS; INVOLVEMENT OF THE SEROMA CAVITY AROUND THE TOTAL HIP ARTHROPLASTY. UPON IMPLANTATION AT THE PRIMARY SURGERY, THERE WAS NOTED TO BE A SPLIT IN THE CALCAR. THE ACETABULAR CUP, FEMORAL STEM AND FEMORAL STEM SLEEVE ADDED TO COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 46 NONE KWA DEPUY INTERNATIONAL, LTD. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention