BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 43

    MDR report key: 4222294 · Received November 3, 2014

    Report

    Report Number
    1818910-2014-31057
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 9, 2014
    Report Date
    November 25, 2014
    Manufacturer
    DEPUY INTERNATIONAL 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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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 THIS INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED. DEPUY SYNTHES HAS BEEN INFORMED THAT THE CATALOG NUMBER AND LOT NUMBER IS NOT AVAILABLE.

    Description of Event or Problem · 1

    ASR REVISION REPORTED VIA SALES REP; ASR XL; RIGHT; PAIN, METALLOSIS 'DELAMINATED ACETABULAR CUP'. SURGEON WILL NOT PROVIDE ADDITIONAL INFORMATION. LOOSENING (CUP).

    Description of Event or Problem · 1

    UPDATE REC¿D 11/25/2014 - MEDICAL RECORDS RECEIVED. UPON REVISION, OSTEOLYSIS WAS NOTED. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703238 ASR UNI FEMORAL IMPL SIZE 43 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL LTD.-8010379 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention