BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR FEM IMP SIZE 57

    MDR report key: 2159070 · Received July 1, 2011

    Report

    Report Number
    1818910-2011-11758
    Event Type
    Injury
    Date Received
    July 1, 2011
    Date of Event
    May 17, 2007
    Report Date
    January 14, 2015
    Manufacturer
    DEPUY INTERNATIONAL LTD.
    Product Code
    KXA
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    CDEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    CORRECTED/UPDATED DATA: (DATE OF REPORT); (DATE OF IMPLANT); (DATE RECEIVED BY MANUFACTURER). DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    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 THIS CASE CLOSED TO CAPA.

    Description of Event or Problem · 1

    THE PT HAS HAD AN ASR REVISION. SPECIFIC DETAILS REGARDING THE REPORT ARE UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A REVISION ON THE ASR LEFT HIP IMPLANT. THE REASON FOR THE REVISION WAS DUE TO A FEMORAL NECK FRACTURE (BEYOND 3 MONTHS OF POST OP).

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT - (B)(4). ASR REVISION, ASR XL ACETABULAR SYSTEM (LEFT); REASON(S) FOR REVISION: FEMORAL NECK FRACTURE ON RESURFACING (BEYOND 3 MONTHS OF POST OP) INCORRECT SEE BELOW. PRIMARY SURGERY WAS (B)(6) 2006, WHICH WAS A RESURFACING, 999805057 ASR FEMORAL IMPLANT SIZE 57 1175682, 999805764 ASR ACET IMPLANT SIZE 64MM 1870319. REVISION SURGERY ON (B)(6) 2007, WHICH WAS THEN AN XL IMPLANT, 999800102 ASR UNIPOLAR SLEEVE ADAPTOR 2331576 L, 999890157 ASR UNI FEMORAL HEAD SIZE 57MM 2193007 L. UPDATE RECEIVED 25TH JULY, 2013. REASON FOR REVISION AMENDED. REASON(S) FOR REVISION: COMPONENT LOOSENING (HEAD). UPDATE 14 JAN 2015. XL PRODUCTS REVISION SURGERY SCHEDULED FOR (B)(6) 2015. ADDED UNKNOWN STEM AND UPDATED ALL PRODUCTS. ADDED ALVAL / SOFT TISSUE REACTION AS REASON FOR XL REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL ASR FEM IMP SIZE 57 HIP FEMORAL HEAD KXA DEPUY INTERNATIONAL LTD. NA 1175682

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention