BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 58

    MDR report key: 1902084 · Received November 10, 2010

    Report

    Report Number
    1818910-2010-07734
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    December 2, 2008
    Report Date
    April 11, 2015
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    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. ALTHOUGH THE SPECIFIC REASON FOR THE PATIENT'S REVISION IS UNKNOWN, BECAUSE THE PATIENT'S CLAIM HAS BEEN APPROVED BY DEPUY'S THIRD-PARTY CLAIMS ADMINISTRATOR, IT IS REASONABLE TO CONCLUDE THAT THE REASON FOR THE REVISION HAS BEEN DETERMINED TO BE PRODUCT-RELATED.

    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).

    Additional Manufacturer Narrative · 1

    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

    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

    ASR HIP REVISION - RIGHT HIP.

    Description of Event or Problem · 1

    REASON(S) FOR REVISION: ALVAL / SOFT TISSUE.

    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 - ASR HIP REVISION - BILATERAL. PRIMARY SURGERY (B)(6). REVISION (B)(6). DATE OF REVISION: (B)(6) 2008 (RIGHT) (B)(6) 2011 (LEFT). UPDATE: HOSPITAL NAME RECEIVED 30 APR 2012. UPDATE: ADDED REASON FOR REVISION. RECEIVED: SEPTEMBER 19TH 2012. REASON(S) FOR REVISION: ALVAL / SOFT TISSUE. UPDATE: ADDED PRODUCT. RECEIVED:DECEMBER 28TH 2012. UPDATE 13 APR 2015 - UPDATE RECEIVED WITH STEM AND SLEEVE. REASON FOR REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL ASR ACET IMP SIZE 58 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 8010379 NA 2153652

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention