BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 49

    MDR report key: 2820771 · Received November 6, 2012

    Report

    Report Number
    1818910-2012-22863
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    April 25, 2016
    Report Date
    October 8, 2012
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    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

    (B)(4). LITIGATION ALLEGES PATIENT HAD PAIN AFTER ASR HIP IMPLANT. DEPUY STILL 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

    (B)(4).

    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

    ADDITIONAL NARRATIVE: NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGAL SYSTEM) COMPLAINT NUMBER WPC (B)(4). REASON FOR ORIGINAL COMPLAINT. PATIENT SEEKING LEGAL ACTION. (BILATERAL) **UPDATE** 12/17/2012 - LITIGATION RECEIVED 11/26/2012 AND ATTACHED. COMPLAINT CHANGED TO LEGAL. LITIGATION ALLEGES PATIENT HAD PAIN AFTER ASR HIP IMPLANT. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. THE REPORTED EVENT HAS BEEN EVALUATED AND WILL BE MONITORED. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    PATIENT SEEKING LEGAL ACTION. (BILATERAL)

    Description of Event or Problem · 1

    SUPPLEMENTAL INFORMATION RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY LITIGATED, IT WAS REPORTED THAT THE PATIENT HAD A REVISION ON (B)(6) 2016 DUE TO PAIN AND SUFFERING, EMOTIONAL DISTRESS. ADDED UNKNOWN ASR SLEEVE PRODUCT. UPDATED THE TWO PRODUCT INFORMATION. THERE ARE NO MEDICAL RECORDS AND LABORATORY VALUES PROVIDED. THERE IS NO NEW INFORMATION ADDED THAT CHANGES THE EXISTING MDR DECISION. PATIENT IS BILATERAL. THIS COMPLAINT WAS UPDATED ON: (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 49 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL LTD. 8010379 2710342

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other