BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIDENTIFIED DEPUY STEM

    MDR report key: 4090970 · Received September 15, 2014

    Report

    Report Number
    1818910-2014-28068
    Event Type
    Injury
    Date Received
    September 15, 2014
    Report Date
    October 2, 2014
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO 510(K) NUMBER PROVIDED BECAUSE THIS IMPLANT IS SOLD INTERNATIONALLY WITH DIFFERENT INDICATIONS FOR USE; IT IS CURRENTLY SOLD IN THE US UNDER A DIFFERENT PART NUMBER. 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)(4) 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. WWCAPA (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

    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, LEFT, XL, REASON FOR REVISION : PERI PROSTHETIC FRACTURE. HEAD AND SLEEVE REVISED ON (B)(6) 2006 AND REPLACED WITH NEW HEAD AND SLEEVE ON THE SAME DAY. CUP REMAINED IN SITU. THIS IS THE SECOND OF 3 REVISIONS. FOR THE 1ST REVISION (B)(4). FOR THE FINAL REVISION (B)(4). BI-LATERAL PATIENT. FOR RIGHT SIDE (B)(4). UPDATE - AMENDED COMPLAINT CATEGORY REASON FOR REVISION TO BONE FRACTURE. ADDED A STEM DUMMY HIP IMPLANT TO THE COMPLAINT. 12TH SEPT 2014. RESPONSE TO PATIENT DEMOGRAPHICS REQUEST. SEE EMAIL DATED 2ND OCTOBER 2014. PATIENT SEX AND DATE OF BIRTH GIVEN BUT THIS IS ALL THE INFO PROVIDED AT THIS TIME.

    Description of Event or Problem · 1

    ASR REVISION, LEFT, XL. REASON FOR REVISION : PERI PROSTHETIC FRACTURE. HEAD AND SLEEVE REVISED ON (B)(6) 2006 AND REPLACED WITH NEW HEAD AND SLEEVE ON THE SAME DAY. CUP REMAINED IN SITU. THIS IS THE SECOND OF 3 REVISIONS. FOR THE 1ST REVISION SEE COM (B)(4). FOR THE FINAL REVISION SEE COM (B)(4). BI-LATERAL PATIENT. FOR RIGHT SIDE SEE COM (B)(4). UPDATE - AMENDED COMPLAINT CATEGORY REASON FOR REVISION TO BONE FRACTURE. ADDED A STEM DUMMY HIP IMPLANT TO THE COMPLAINT. (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568537 UNIDENTIFIED DEPUY STEM HIP FEMORAL STEM/SLEEVE KWA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention