BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR FEM IMP SIZE 49

    MDR report key: 3020966 · Received March 26, 2013

    Report

    Report Number
    1818910-2013-03590
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    March 13, 2013
    Report Date
    April 25, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KXA
    Removal / Correction Number
    Z- 1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    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.

    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.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    NEW (B)(6) RECORD CREATED IN ORDER TO UPDATE (B)(6) (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT - ASR REVISION. ASR RESURFACING - LEFT. REASON(S) FOR REVISION: PAIN, COMPONENT LOOSENING - HEAD AND ALVAL / SOFT TISSUE REACTION. (B)(6) REFERENCE NUMBER: (B)(4). UPDATE RECEIVED: 21ST APRIL 2014 - LEFT NOTES(SEE ADDITIONAL INFORMATION), CROSS REFERENCED, ADDED PATIENT GENDER: MALE, ADDED PATIENT NAME, ADDED PATIENT ID (INITIALS), ADDED PATIENT BIRTH YEAR (SEE ADDITIONAL INFORMATION), ADDED PATIENT WEIGHT AND ADDED PATIENT HEIGHT. BI-LATERAL PATIENT - PLEASE SEE (B)(4) FOR RIGHT SIDE REVISION.

    Description of Event or Problem · 1

    ASR REVISION, ASR RESURFACING - LEFT, REASON(S) FOR REVISION: PAIN, COMPONENT LOOSENING - HEAD AND ALVAL / SOFT TISSUE REACTION.

    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 - LEFT. REASON(S) FOR REVISION: PAIN, COMPONENT LOOSENING - HEAD AND ALVAL / SOFT TISSUE REACTION. (B)(4). UPDATE RECEIVED: 21ST APRIL 2014 - LEFT NOTES(SEE ADDITIONAL INFORMATION), CROSS REFERENCED, ADDED PATIENT GENDER: MALE, ADDED PATIENT NAME, ADDED PATIENT ID (INITIALS), ADDED PATIENT BIRTH YEAR (SEE ADDITIONAL INFORMATION), ADDED PATIENT WEIGHT AND ADDED PATIENT HEIGHT. BI-LATERAL PATIENT - PLEASE SEE (B)(4) FOR RIGHT SIDE REVISION. UPDATE RECEIVED: 25TH APRIL 2014 - CONFIRMED DETAILS DOCUMENT, ADDED PATIENT AGE, ADDED PATIENT DATE OF BIRTH, AMENDED LOT NUMBERS FOR BOTH PRODUCTS AND AMENDED MANUFACTURING DATES FOR CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123567 TOTAL ASR FEM IMP SIZE 49 ASR TOTAL HIP REPLACEMENT KXA DEPUY INTERNATIONAL LTD. 8010379 2759887

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention