BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR IMPLANT 52

    MDR report key: 2972004 · Received February 21, 2013

    Report

    Report Number
    1818910-2013-02360
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    May 17, 2011
    Report Date
    May 13, 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
    US
    Reporter Occupation
    PATIENT

    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. 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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 - LEFT; REASON(S) FOR REVISION: PAIN.

    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 XL - LEFT. REASON(S) FOR REVISION: PAIN. UPDATE- ADDED CUP AND STEM, DID FINAL MED DEV, TAKEN FROM CLAIMSUITE DATED 14TH FEB 2013. UPDATE - AMENDED HIP SIDE AND SURGERY DATE TAKEN FROM CLAIMSUITE DATED 3RD OCTOBER 2013. RIGHT SIDE. UPDATE RECEIVED 13TH MAY 2014. LOT NUMBER ADDED FOR TAPER SLEEVE. ADDITIONAL REASON FOR REVISION ADDED. NEW FIELDS COMPLETED. PATIENT INITIALS ADDED. REASON(S) FOR REVISION: PAIN, METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76904 ASR ACETABULAR IMPLANT 52 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD - 8010379 2646131

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention