BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN DEPUY ASR HIP

    MDR report key: 1940216 · Received December 23, 2010

    Report

    Report Number
    1818910-2010-09526
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Date of Event
    November 23, 2010
    Report Date
    September 4, 2013
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION AND JUSTIFICATION STATUS: FOLLOWING INVESTIGATION BY BIOENGINEERING, IT WAS REPORTED THAT: IT IS LIKELY IN THIS CASE THAT AN UNKNOWN COMBINATION OF SEVERAL FACTORS OCCURRED ¿ SUCH AS PATIENT FACTORS, SURGICAL PROCEDURE, SURGICAL PROCESS AND IMPLANT DESIGN. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION; IT SHALL BE ENTERED ONTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. SHOULD FURTHER INFORMATION BE RECEIVED, THEN FURTHER INVESTIGATION SHALL BE COMPLETED. 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

    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. THIS IMPLANT IS NOT SOLD IN THE US TO BE IMPLANTED FOR THIS INDICATION; IT WOULD BE SOLD UNDER A DIFFERENT PART NUMBER SINCE IT IS ONLY INDICATED TO BE USED AS A HEMI IN THE US AT THIS TIME. 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

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    RECOMMENDED ASR REVISION - LEFT HIP.

    Description of Event or Problem · 1

    REASON FOR REVISION: CUP AND LINER LOCKED TOGETHER.

    Description of Event or Problem · 1

    REVISED FOR PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR HIP 87KWA KWA DEPUY INTERNATIONAL, LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention