BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 48

    MDR report key: 2113084 · Received May 18, 2011

    Report

    Report Number
    1818910-2011-05277
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    February 7, 2011
    Report Date
    February 11, 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
    SZ
    Reporter Occupation
    OTHER

    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).

    Additional Manufacturer Narrative · 1

    NO 510K# SUBMITTED AS DEPUY ORTHOPAEDICS SELLS A SIMILAR PRODUCT (OR THE SAME PRODUCT WITH A DIFFERENT PRODUCT CODE) IN THE UNITED STATES. 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

    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

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT - ASR; CLAIMSUITE REF: (B)(4). ASR XL ACETABULAR SYSTEM (LEFT); REASON(S) FOR REVISION: COMPONENT LOOSENING. COMMENTS RECEIVED FROM (B)(6) ON 11TH AUG 2011. "THE OPERATION I HAVE REPORTED AS THE FIRST REVISION (DATE (B)(6) 2010) IS TECHNICALLY NOT A REVISION. THE IMPLANT WERE NOT REPLACED (B)(6) 2010. THE SECOND OPERATION (DATE (B)(6) 2011), THE TECHNICALLY REVISION WERE THE IMPLANT IS REPLACED." CLAIMSUITE REF: (B)(4). UPDATE- ADDED HOSPITAL, SURGEON. TAKEN FROM CLAIMSUITE DATED 14TH FEB 2013. UPDATE 11 FEB 2015 - ADDED PAIN AND NOISE AS REASONS FOR REVISION.

    Description of Event or Problem · 1

    SURGICAL INTERVENTION DUE TO ASR RECALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL ASR ACET IMP SIZE 48 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 8010379 NA 2272152

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention