BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 56

    MDR report key: 2832422 · Received November 14, 2012

    Report

    Report Number
    1818910-2012-24891
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    January 21, 2015
    Report Date
    January 21, 2015
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    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. (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

    LITIGATION ALLEGES PATIENT HAD PAIN AND DISCOMFORT WHICH AFFECTS ABILITY TO WALK, SLEEP AND MOVE; AND ELEVATED METAL LEVELS IN BLOOD AFTER ASR HIP IMPLANT.

    Description of Event or Problem · 1

    UPDATE 21 JAN 2015 - ASR CUP REVISION. HEAD & CUP WERE REMOVED DUE TO PAIN. CUP WAS REPLACED WITH A GRIPTION MULTIHOLE & A +4 NEUTRAL LINER. STEM REPORTED AS REMAINING IN SITU. ADDED DOR, UPDATED DOI, ADDED SURGEON AND SALES REP INFORMATION, PATIENT WEIGHT AND STEM AND SLEEVE PRODUCTS. UPDATE REC'D 1/28/2015- MEDICAL RECORDS RECEIVED. UPON REVISION, METAL ON METAL NECROTIC DEBRIS, AND MINIMAL GROWTH ON THE BACK OF THE ACETABULAR CUP WERE NOTED. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PATIENT HAD PAIN AND DISCOMFORT WHICH AFFECTS ABILITY TO WALK, SLEEP AND MOVE; AND ELEVATED METAL LEVELS IN BLOOD AFTER ASR HIP IMPLANT. **UPDATE** (B)(4) 2012 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION AND DATE OF IMPLANT FOR THE LEFT SIDE AND ALSO DATE OF IMPLANT FOR THE RIGHT SIDE. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 56 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2297157

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other| R