BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 60

    MDR report key: 2880161 · Received December 19, 2012

    Report

    Report Number
    1818910-2012-26971
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    December 10, 2012
    Report Date
    August 19, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS COMPLAINT CLOSED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    (B)(4). LITIGATION ALLEGES PATIENT HAD PAIN AND HIGH CONCENTRATION OF VARIOUS METALLIC ELEMENTS IN BLOOD 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

    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

    PATIENT WAS REVISED DUE TO OSTEOLYSIS ON BOTH HIPS. PATIENT IS BILATERAL. (RIGHT AND LEFT HIP).

    Description of Event or Problem · 1

    **UPDATE** - BILATERAL PATIENT - MEDICAL RECORDS WERE RECEIVED (B)(6) 2013 FOR BOTH HIPS. LEFT HIP: REVISION OPERATIVE REPORT INDICATES THE FOLLOWING: LARGE JOINT EFFUSION AND ADVERSE LOCAL TISSUE REACTION; CORROSION AT THE HEAD/TRUNNION JUNCTION; OSTEOLYSIS. RIGHT HIP: LARGE HIP JOINT EFFUSION WITH NECROTIC DEBRIS; CORROSION AT THE HEAD TRUNNION JUNCTION OF THE FEMORAL COMPONENT; OSTEOLYTIC LESION. TWO ADAPTER SLEEVES AND TWO FEMORAL STEMS ADDED TO COMPLAINT - ONE SLEEVE AND ONE STEM FOR EACH SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 60 ACETABULAR CUP KWA DEPUY INTERNATIONAL 2159202

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention