BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 46

    MDR report key: 3230648 · Received July 16, 2013

    Report

    Report Number
    1818910-2013-21385
    Event Type
    Injury
    Date Received
    July 16, 2013
    Report Date
    July 9, 2013
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. REF. (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.

    Description of Event or Problem · 1

    PATIENT CONTACTED BROADSPIRE TO INITIATE CLAIM. PATIENT REPORTED REVISION SURGERY. REASON FOR REVISION IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. **UPDATE** (B)(4) 2011 - MEDICAL RECORDS WERE RECEIVED. THE REVISION OPERATIVE REPORT INDICATES THE PATIENT WAS REVISED ON (B)(6) 2010 DUE TO RECURRENCE OF ADVERSE SOFT TISSUE REACTION. ADDITIONALLY IT WAS REPORTED THAT THE PATIENT HAD NUMEROUS DISLOCATION OF THE RIGHT HIP; HOWEVER, SHE WAS NOT FULLY COMPLIANT WITH ALL OF HER POSTOPERATIVE RESTRICTIONS. THE COMPLAINT WAS REOPENED TO UPDATE THE EVENT DESCRIPTION AND THE PRODUCT INVOLVED. *UPDATE**LITIGATION RECEIVED ALLEGING THAT THE PATIENT SUFFERS FROM PAIN, ELEVATED METAL IONS, PSEUDOTUMORS, AND PARTICLE DISEASE. ALSO ALLEGED IS DECREASED RANGE OF MOTION AND DIFFICULTY AMBULATING. AN ACETABULAR CUP HAS BEEN ADDED TO ADDRESS THESE ISSUES. PART/LOT IN FOR HAVE BEEN IDENTIFIED THROUGH AN INVOICE SEARCH. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE OUTCOME OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328077 ASR ACETABULAR CUPS 46 ACETABULAR CUP KWA DEPUY INTL., LTD. - 8010379 2190323

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention