BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 48

    MDR report key: 3113327 · Received May 15, 2013

    Report

    Report Number
    1818910-2013-05920
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    April 10, 2013
    Report Date
    May 2, 2013
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. THE COMPLAINT IS CONSIDERED 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. (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

    ADDED: UDI AND EXPIRATION DATE AND PATIENT CODE. CORRECTED: DOB.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: 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. THE INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS WAS CONDUCTED UNDER MDD CAPA- (B)(4). ONGOING POST MARKET SURVEILLANCE IS CONDUCTED PER OUR PROCEDURES FOR THIS PRODUCT. DEVICE HISTORY LOT: NULL. DEVICE HISTORY BATCH: NULL. DEVICE HISTORY REVIEW: NULL. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH , A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    LITIGATION ALLEGES ACETABULAR CUP EVENTUALLY PRODUCED METALLIC DEBRIS, AND/OR LOOSENED FROM ACETABULUM, CAUSED PAIN, PRODUCED ABNORMAL BLOOD METAL ION, AND INHIBITED PATIENTS ABILITY TO WALK AFTER ASR HIP IMPLANT.

    Description of Event or Problem · 1

    AFTER REVIEW OF MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL COMPONENT, OSTEOLYSIS AND POSSIBLE INFECTION OF THE RIGHT HIP. REVISION NOTE REPORTED A YELLOWISH FLUID THAT CAME OUT FROM THE CAPSULE AND SCAR AROUND HIP. FEMORAL COMPONENT WAS NOTED TO BE LOOSE. THE TAPER WAS NOTED TO NOT BE IN GREAT SHAPE IT TOGGLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215224 ASR ACETABULAR CUPS 48 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL LTD. 8010379 2245912

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention