BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 60

    MDR report key: 3040484 · Received April 8, 2013

    Report

    Report Number
    1818910-2013-04670
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    February 13, 2015
    Report Date
    February 13, 2015
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PATIENT

    Narratives

    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. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY.

    Additional Manufacturer Narrative · 1

    DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    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 THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    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 RESURFACING - RIGHT HIP; REASON(S) FOR REVISION: PAIN; COMPONENT LOOSENING.

    Description of Event or Problem · 1

    ASR REVISION; ASR RESURFACING PRODUCT - RIGHT HIP; REASON FOR REVISION: COMPONENT LOOSENING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COMPONENT THAT LOOSENED WAS THE ACETABULAR CUP.

    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 RESURFACING PRODUCT - RIGHT, REASON(S) FOR REVISION: COMPONENT LOOSENING. UPDATE FORM 73 RECEIVED APRIL 16TH, 2013. PATIENT ID, ADDITIONAL REASON FOR REVISION ADDED. REASON(S) FOR REVISION: PAIN. UPDATE RECEIVED APRIL 24TH, 2013 - THE ASR ACETABULAR COMPONENT WAS REMOVED WITH EASE INDICATING MICRO MOTION AND LOOSENING. UPDATE - MARKED AS LEGAL, ADDED PATIENT NAME, GENDER AND DATE OF BIRTH, ATTACHED LEGAL LETTER. TAKEN FROM LEGAL LETTER DATED 13TH FEB 2015. PATIENT NAME: (B)(6), GENDER - MALE, DATE OF BIRTH - (B)(6) 1950.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142925 TOTAL ASR ACET IMP SIZE 60 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 8010379 2823992

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention