BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 49

    MDR report key: 1945788 · Received December 30, 2010

    Report

    Report Number
    1818910-2010-09972
    Event Type
    Injury
    Date Received
    December 30, 2010
    Date of Event
    November 24, 2010
    Report Date
    December 20, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KXA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO 510K# SUBMITTED AS DEPUY ORTHOPAEDICS SELLS A SIMILAR PRODUCT (OR THE SAME PRODUCT WITH A DIFFERENT PRODUCT CODE) IN THE US. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    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. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY. THIS IMPLANT IS NOT SOLD IN THE US TO BE IMPLANTED FOR THIS INDICATION; IT WOULD BE SOLD UNDER A DIFFERENT PART NUMBER SINCE IT IS ONLY INDICATED TO BE USED AS A HEMI IN THE US AT THIS TIME. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A LOT SPECIFIC COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. ALTHOUGH THE ROOT CAUSE CANNOT BE DETERMINED, IT IS KNOWN THAT THE ASR PLATFORM WAS VOLUNTARILY RECALLED IN AUGUST OF 2010 FOLLOWING AN HHE (HEALTH HAZARD EVALUATION). FURTHER ANALYSIS REGARDING THE ASR PRODUCT FAMILY WILL BE DOCUMENTED, AS DETERMINED PERTINENT, IN (B)(4). BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR FURTHER CORRECTIVE ACTION IS NOT INDICATED AT THIS TIME. 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

    PT PRESENTED WITH UNDIAGNOSED PAIN. RECOGNISED ASR PT. GREY SLUDGE FLUID FOUND IN JOINT SPACE, PARTIAL SYNOVIAL THICKENING.

    Description of Event or Problem · 1

    REVISED FOR LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY ASR XL FEM IMP SIZE 49 TOTAL HIP PROSTHESIS KXA DEPUY INTERNATIONAL, LTD. NA 2446659

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention