BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 58

    MDR report key: 2113330 · Received May 20, 2011

    Report

    Report Number
    1818910-2011-08903
    Event Type
    Injury
    Date Received
    May 20, 2011
    Date of Event
    December 3, 2013
    Report Date
    January 28, 2014
    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
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    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. REF. WWCAPA (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

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE SINCE SURGERY, PT HAS SUFFERED SYMPTOMS INCLUDING, BUT NOT LIMITED TO PAIN, SWELLING, SORENESS, DIFFICULTY WALKING, AND DECREASED MOBILITY.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE SINCE SURGERY, PATIENT HAS SUFFERED SYMPTOMS INCLUDING, BUT NOT LIMITED TO PAIN, SWELLING, SORENESS, DIFFICULTY WALKING, AND DECREASED MOBILITY. UPDATE: (B)(6) 2012 - PLAINTIFFS PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION. 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**(B)(4) 2013 - SALES REP REPORTED REVISION SURGERY. PATIENT WAS REVISED TO ADDRESS INSTABILITY. ELECTIVE SURGERY. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: (B)(4) 2013.

    Description of Event or Problem · 1

    UPDATE: (B)(4) 2014 - MEDICAL RECORDS RECEIVED. PATIENT WAS REVISED TO ADDRESS FLUID, CAPSULITIS, THICK FIBROUS TISSUE, METAL REACTION, CORROSION AT THE TRUNNION, INFLAMED TISSUE, METAL DEBRIS, AND A CYST. THE STEM AND SLEEVE HAVE BEEN ADDED TO THE COMPLAINT. STEM REMAINED IN SITU. THIS COMPLAINT WAS UPDATED ON: (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 58 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL, LTD. NA 2352762

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention