BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 54

    MDR report key: 3920406 · Received July 8, 2014

    Report

    Report Number
    1818910-2014-22990
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    June 12, 2014
    Report Date
    September 1, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD.
    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

    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.

    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.

    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. 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. REF. (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.

    Description of Event or Problem · 1

    ASR REVISION.HIP(S) TO BE REVISED: UNKNOWN.TYPE OF HIP REPLACEMENT PRODUCT: UNKNOWN.REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION.UPDATE - ADDED HIP SIDE, TYPE OF REPLACEMENT, PRODUCTS X4 . TAKEN FROM CLAIMSUITE DATED 10TH JULY 2014.RIGHT.ASR XL.

    Description of Event or Problem · 1

    ASR REVISION. HIP(S) TO BE REVISED: UNKNOWN. TYPE OF HIP REPLACEMENT PRODUCT: UNKNOWN. REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION. UPDATE - ADDED HIP SIDE, TYPE OF REPLACEMENT, PRODUCTS X4 . TAKEN FROM CLAIMSUITE DATED 10TH JULY 2014. RIGHT. ASR XL. SURGEON CONFIRMATION FORM RECEIVED (B)(6). REVISION DATE AMENDED. ADDITIONAL SURGEON AND HOSPITAL ADDED. ADDITIONAL REASONS FOR REVISION ADDED. REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION, PAIN AND NOISE, TINNITUS.

    Description of Event or Problem · 1

    ASR REVISION, HIP(S) TO BE REVISED: UNKNOWN, TYPE OF HIP REPLACEMENT PRODUCT: UNKNOWN, REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397405 TOTAL ASR ACET IMP SIZE 54 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 2036217

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention