BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 54

    MDR report key: 3166388 · Received June 12, 2013

    Report

    Report Number
    1818910-2013-18744
    Event Type
    Injury
    Date Received
    June 12, 2013
    Date of Event
    June 1, 2013
    Report Date
    March 11, 2015
    Manufacturer
    DEPUY INTERNATIONAL LTD.
    Product Code
    KWA
    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

    DEPUY STILL CONSIDERS THIS COM CLOSED TO CAPA.

    Additional Manufacturer Narrative · 1

    NO 510(K) NUMBER PROVIDED BECAUSE THIS IMPLANT IS SOLD INTERNATIONALLY WITH DIFFERENT INDICATIONS FOR USE; IT IS CURRENTLY SOLD IN THE US UNDER A DIFFERENT PART NUMBER. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY. 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.

    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

    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 XL - RIGHT. REASON(S) FOR REVISION: "PAIN AND METALLOSIS, HIGH SERUM CO, CR LEVELS." THIS IS THE SECOND PART OF A RESURFACING TO XL REVISION. (B)(4) FOR REVISION OF THE RESURFACING HEAD. CUP IMPLANTED (B)(6) 2013. FEMORAL HEAD, TAPER SLEEVE AND STEM IMPLANTED (B)(6) 2010. ALL COMPONENTS REVISED ON (B)(6) 2013. BILATERAL PATIENT. (B)(6).

    Description of Event or Problem · 1

    ASR REVISION, ASR XL - RIGHT, REASON(S) FOR REVISION: "PAIN AND METALLOSIS, HIGH SERUM CO, CR LEVELS". THIS IS THE SECOND PART OF A RESURFACING TO XL REVISION. SEE COM 010958 FOR REVISION OF THE RESURFACING HEAD. CUP IMPLANTED (B)(6) 2007. FEMORAL HEAD, TAPER SLEEVE AND STEM IMPLANTED (B)(6) 2010. ALL COMPONENTS REVISED ON (B)(6) 2013. BILATERAL PATIENT. (B)(4) FOR OTHER HIP. 11 MARCH 2015 - UPDATE - ADDED IMPLANT DATE, MANUFACTURING FACILITIES AND UNKNOWN STEM.

    Description of Event or Problem · 1

    ASR REVISION, ASR XL - RIGHT, REASON(S) FOR REVISION: "PAIN AND METALLOSIS, HIGH SERUM CO, CR LEVELS". THIS IS THE SECOND PART OF A RESURFACING TO XL REVISION. (B)(4) FOR REVISION OF THE RESURFACING HEAD. CUP IMPLANTED (B)(6) 2007. FEMORAL HEAD, TAPER SLEEVE AND STEM IMPLANTED (B)(6) 2010. ALL COMPONENTS REVISED ON (B)(6) 2013. BILATERAL PATIENT. (B)(6) FOR OTHER HIP. 11 MARCH 2015 - UPDATE - ADDED IMPLANT DATE, MANUFACTURING FACILITIES AND UNKNOWN STEM 11 MARCH 2015 - ADDED MANU AND EXP DATES TO PRODUCTS, ADDED MENTAL IONS FO REVISION REASON - KF 30/03/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266034 TOTAL ASR ACET IMP SIZE 54 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 2264786

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention