BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL ASR ACET IMP SIZE 50

    MDR report key: 1973489 · Received January 12, 2011

    Report

    Report Number
    1818910-2011-00010
    Event Type
    Malfunction
    Date Received
    January 12, 2011
    Report Date
    December 15, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    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.

    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

    RECOMMENDED ASR REVISION - LEFT HIP.

    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 - RECOMMENDED ASR REVISION - LEFT HIP. PRODUCT NAME: ASR XL ACETABULAR SYSTEM (LEFT). UPDATE - ADDED REASON FOR REVISION, HOSPITAL, SURGEON, REVISION DATE, AND 3 PRODS. (CUP HEAD AND SLEEVE) TAKEN FROM CLAIMSUITE DATED 9TH SEPT 2014. REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION.

    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: RECOMMENDED ASR REVISION - LEFT HIP. PRODUCT NAME: ASR XL ACETABULAR SYSTEM (LEFT) . UPDATE - ADDED REASON FOR REVISION, HOSPITAL, SURGEON, REVISION DATE, AND 3 PRODS. (CUP HEAD AND SLEEVE) TAKEN FROM CLAIMSUITE DATED 9TH SEPT 2014. REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION. UPDATE - ADDED ADDITIONAL REASON FOR REVISION AND EXPIRY DATES. TAKEN FROM CLAIMSUITE DATED 15TH DECEMBER 2014 REASON(S) FOR REVISION: HIGH COBALT/CHROMIUM LEVELS.

    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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention