BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 53

    MDR report key: 4826402 · Received June 9, 2015

    Report

    Report Number
    1818910-2015-22993
    Event Type
    Injury
    Date Received
    June 9, 2015
    Date of Event
    June 29, 2012
    Report Date
    May 29, 2015
    Manufacturer
    DEPUY INTERNATIONAL LTD.8010379
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    ASR REVISION ASR XL - RIGHT REASON(S) FOR REVISION: PAIN, ALVAL THIS IS A TWO PART REVISION - RESURFACE TO XL - THE ACETABULAR CUP REMAINED IN SITU WHEN XL IMPLANTED - FOR RESURFACE PLEASE SEE COM: (B)(4) XL HEAD WAS NOTED IN RESURFACE DINT:15802 - KF (B)(4) 2015 (B)(4) 2015 - UPDATE - RCVD EMAIL TO CONF THE SLEEVE - ADDED TO COM. THE STEM WAS A JRI FULONG STEM - (COMPETITOR) - KF (B)(4) 2015 (B)(4) 2015 - UPDATE - MDR VOIDED ON THE STEM AS CONF THAT IT WAS A COMPETITOR STEM AND REMOVED STEM DETAILS PAGE FROM COM. - KF (B)(4) 2015 UPDATE (B)(4) 2017: CLAIM LETTER, ASR SNAPSHOT, AND RECONCILIATION PATIENT NAME RECEIVED. ADDED COMPLAINANT INFORMATION. THIS COMPLAINT WAS UPDATED ON: (B)(4) 2017. 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ASR REVISION; ASR XL - RIGHT; REASON(S) FOR REVISION: PAIN, ALVAL. THIS IS A TWO PART REVISION - RESURFACE TO XL - THE ACETABULAR CUP REMAINED IN SITU WHEN XL IMPLANTED - FOR RESURFACE PLEASE SEE COM: (B)(4). XL HEAD WAS NOTED IN RESURFACE DINT: (B)(4). 04 JUNE 2015 - UPDATE - RCVD EMAIL TO CONF THE SLEEVE - ADDED TO COM. THE STEM WAS A JRI FULONG STEM - (COMPETITOR) - (B)(4). 05 JUNE 2015 - UPDATE - MDR VOIDED ON THE STEM AS CONF THAT IT WAS A COMPETITOR STEM AND REMOVED STEM DETAILS PAGE FROM COM. (B)(4).

    Description of Event or Problem · 1

    UPDATE JUL 24, 2017: CLAIM LETTER, ASR SNAPSHOT, AND RECONCILIATION PATIENT NAME RECEIVED. ADDED COMPLAINANT INFORMATION. THIS COMPLAINT WAS UPDATED ON: SEP 13, 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373120 DEPUY ASR XL FEM IMP SIZE 53 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL LTD.8010379 1173871

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention