BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 51

    MDR report key: 3870794 · Received June 12, 2014

    Report

    Report Number
    1818910-2014-20914
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 22, 2014
    Report Date
    September 5, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD.-8010379
    Product Code
    KXA
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE RCVD BY MFR: 1/10/2016. UPDATE 1/10/2016 MEDICAL RECORDS RECEIVED. MEDICAL RECORDS REVIEWED FOR MDR REPORTABILITY. THE PRIMARY SURGERY WAS COMPLETED ON 11/22/2008 IN INDIA WITH REVISION SURGERY IN THE UNITED STATES. REVISION SURGICAL REPORT NOTED THE STEM HAD VERY LITTLE ANTEVERSION AND WAS SOMEWHAT NEUTRAL BUT BECAUSE OF STABILITY IT WAS NOT REVISED. PART/LOT STICKERS FOR THE HEAD AND SLEEVE RECEIVED AND UPDATED. THE COMPLAINT WAS UPDATED ON: JAN 29, 2016. PRODUCT: 999890151 MDR : 087857. DEPUY ASR XL FEM IMP SIZE 51, PART NUMBER: 999890151, LOT NUMBER: 2576441. 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. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED AT THIS TIME.

    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. (B)(4). DEPUY CONSIDERS THIS INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED. ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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 INVESTIGATION CLOSED.

    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. (B)(4). DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    ASR REVISION REPORTED VIA SALES REP; ASR XL; LEFT. REASON(S) FOR REVISION: PAIN.

    Description of Event or Problem · 1

    UPDATE 1/10/2016 MEDICAL RECORDS RECEIVED. MEDICAL RECORDS REVIEWED FOR MDR REPORTABILITY. THE PRIMARY SURGERY WAS COMPLETED ON (B)(6) 2008 IN (B)(6) WITH REVISION SURGERY IN THE UNITED STATES. REVISION SURGICAL REPORT NOTED THE STEM HAD VERY LITTLE ANTEVERSION AND WAS SOMEWHAT NEUTRAL BUT BECAUSE OF STABILITY IT WAS NOT REVISED. PART/LOT STICKERS FOR THE HEAD AND SLEEVE RECEIVED AND UPDATED. THE COMPLAINT WAS UPDATED ON: JAN 29, 2016.

    Description of Event or Problem · 1

    UPDATE REC'D 7/18/2014 - MEDICAL RECORDS RECEIVED. PRODUCT/LOT INFORMATION PROVIDED FOR STEM AND SLEEVE. DOI PROVIDED. UPON REVISION, ALVAL, SOFT TISSUE AND ACETABULAR DEFECTS, INFLAMMATORY CHANGE, AND OSTEOLYSIS WERE NOTED. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION. THIS COMPLAINT WAS UPDATED ON: 07/23/2014.

    Description of Event or Problem · 1

    UPDATE REC'D (B)(6) 2014 - LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES ELEVATED METAL IONS AND COBALT AND/OR CHROMIUM POISONING. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346916 DEPUY ASR XL FEM IMP SIZE 51 HIP FEMORAL HEAD KXA DEPUY INTERNATIONAL LTD.-8010379 2576441

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention