BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 48

    MDR report key: 3081163 · Received April 26, 2013

    Report

    Report Number
    1818910-2013-04990
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    March 1, 2011
    Report Date
    August 15, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    Removal / Correction Number
    Z- 1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    ATTORNEY

    Narratives

    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). 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.

    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 REVISION; ASR RESURFACING - RIGHT; REASON(S) FOR REVISION: UNKNOWN.

    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 REVISION. ASR RESURFACING - RIGHT. REASON(S) FOR REVISION: UNKNOWN. BI-LATERAL PATIENT - PLEASE SEE (B)(4) FOR LEFT SIDE REVISION. UPDATE RECEIVED 15TH AND 20TH AUGUST 2014. LOT NUMBERS ADDED. REVISION DATE AMENDED, REVISION REASON ADDED. REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION. CORRECTION RECEIVED 27TH AUGUST 2014. (B)(6) HAS CONFIRMED THAT THE KENNEDYS REVISION DATE IS THE CORRECT DATE. REVISION DATE AMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181293 TOTAL ASR ACET IMP SIZE 48 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 8010379 2523809

    Patients

    Seq Age Sex Outcome Treatment
    1