BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 48

    MDR report key: 1903125 · Received November 17, 2010

    Report

    Report Number
    1818910-2010-07909
    Event Type
    Injury
    Date Received
    November 17, 2010
    Date of Event
    January 8, 2008
    Report Date
    November 20, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWY
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE SPECIFIC REASON FOR THE PATIENT'S REVISION IS UNKNOWN, BECAUSE THE PATIENT'S CLAIM HAS BEEN APPROVED BY DEPUY'S THIRD-PARTY CLAIMS ADMINISTRATOR, IT IS REASONABLE TO CONCLUDE THAT THE REASON FOR THE REVISION HAS BEEN DETERMINED TO BE PRODUCT-RELATED. 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

    THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY. THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(6) 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

    DEPUY STILL CONSIDERS THIS CASE CLOSED TO CAPA. 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

    ASR REVISION - LEFT HIP.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED TO ADDRESS ALVAL.

    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 HIP RESURFACING SYSTEM - LEFT, REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION. CLAIMSUITE REFERENCE (B)(4). UPDATE: DATE OF REVISION, PRODUCTS & SURGEON ADDED, PRIMARY SURGERY DATE AMENDED, CRAWFORD UPDATE SPREADSHEET DATED 8TH NOV 2011. UPDATE - ADDED (B)(6) 47 REF NUMBER, ADDITIONAL REASON FOR REVISION, ADDITIONAL SURGEON AND HOSPITAL AND AMENDED REVISION DATE. TAKEN FROM CLAIMSUITE DATED 20TH NOV 2014. SYSTEM NUMBER: (B)(4), REASON(S) FOR REVISION: PAIN, HOSPITAL: (B)(6) HOSPITAL, SURGEON'S NAME: MR (B)(6), DATE OF REVISION: (B)(6) 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL ASR ACET IMP SIZE 48 HIP ACETABULAR CUP KWY DEPUY INTERNATIONAL LTD. 8010379 NA 1940100

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention