BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 50

    MDR report key: 2141484 · Received June 22, 2011

    Report

    Report Number
    1818910-2011-10976
    Event Type
    Injury
    Date Received
    June 22, 2011
    Date of Event
    May 27, 2011
    Report Date
    September 4, 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
    US
    Reporter Occupation
    UNKNOWN

    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.

    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 PREVIOUSLY LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY.

    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

    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

    THE PT IS SCHEDULED FOR AN ASR REVISION TO ADDRESS LOOSENING.

    Description of Event or Problem · 1

    ASR XL ACETABULAR SYSTEM (RIGHT).

    Description of Event or Problem · 1

    UPDATE - CONFIRMED THAT "COMPONENT LOOSENING" WAS AN INCORRECT REASON FOR REVISION. SEE BELOW FOR CORRECT REASON. TAKEN FROM EMAIL DATED 4TH SEPT 2015. REASON FOR REVISION : 'RAISED METAL IONS AND EVIDENCE OF METALLOSIS AROUND THE IMPLANT'.

    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 . UPDATE: HIP REVISED, SYSTEM USED, PRODUCT DETAILS FOR STEM AND SLEEVE, REASON FOR REVISION RECEIVED 20 JULY 2012 . ASR XL ACETABULAR SYSTEM (RIGHT) . REASON(S) FOR REVISION: COMPONENT LOOSENING - QUERIED WITH CRAWFORDS . UPDATE - RE-CREATED TO CONFIRM WHICH COMPONENT BECAME LOOSE AND CORRECT LOT NUMBER FOR THE CUP. PREVIOUS CUP LOT NUMBER PROVIDED IS INCORRECT. TAKEN FROM CLAIMSUITE DATED 18TH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL ASR ACET IMP SIZE 50 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD - 8010379 NA 2251531

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention