BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL ASR ACET IMP SIZE 54

    MDR report key: 1921210 · Received December 8, 2010

    Report

    Report Number
    1818910-2010-08886
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    December 22, 2010
    Report Date
    November 4, 2012
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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.

    Additional Manufacturer Narrative · 1

    (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

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

    ADDITIONAL NARRATIVE: NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGAL SYSTEM) COMPLAINT NUMBER (B)(4) . REASON FOR ORIGINAL COMPLAINT ¿ ASR REVISION RECOMMENDED REASON FOR REVISION: ALVAL / SOFT TISSUE REACTION. ASR HIP RESURFACING SYSTEM UPDATE: DATE OF REVISION, ADDITIONAL REASON FOR REVISION, SURGEON AND HOSPITAL FROM CRAWFORDS UPDATE SPREADSHEET DATED (B)(6) 2011. 9/12 - UPDATE FROM CRAWFORDS SPREADSHEET DATED (B)(6) 2011- CHANGED REASON FOR REVISION, RIGHT HIP TO BE REVISED. UPDATE- ADDED LOT NUMBERS TO STEM AND SLEEVE TAKEN FROM CLAIMSUITE DATED (B)(6) 2012. THE REPORTED EVENT HAS BEEN EVALUATED AND WILL BE MONITORED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. 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

    IT WAS REPORTED THAT THE PATIENT HAD A REVISION ON THE RIGHT ASR HIP RESURFACING SYSTEM. THE PREVIOUSLY REPORTED CONDITION IS UNCHANGED.

    Description of Event or Problem · 1

    ASR REVISION RECOMMENDED.

    Description of Event or Problem · 1

    UPDATE: THE REASON FOR REVISION IS ALVAL / SOFT TISSUE REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL ASR ACET IMP SIZE 54 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 8010379 NA 1896274

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention