BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 58

    MDR report key: 3241593 · Received July 22, 2013

    Report

    Report Number
    1818910-2013-21837
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    July 3, 2013
    Report Date
    August 20, 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

    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.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    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. 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.

    Description of Event or Problem · 1

    ASR REVISION;ASR XL- RIGHT;REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION.

    Description of Event or Problem · 1

    ASR REVISION; ASR XL- RIGHT; REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION. UPDATE - UPDATED SURGERY DATE TAKEN FROM CLAIMSUITE DATED 2ND AUGUST 2013. BI-LATERAL PATIENT - FOR LEFT SIDE (B)(4). UPDATE 23 JULY 2014 - UPDATED KID AND REVISION SURGERY DATE. UPDATE - FILED OUT MW FIELDS, PREVIOUSLY MISSED, 20TH AUGUST 2014.

    Description of Event or Problem · 1

    ASR REVISION. ASR XL- RIGHT. REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION. UPDATE - UPDATED SURGERY DATE TAKEN FROM CLAIMSUITE DATED 2ND AUGUST 2013. BI-LATERAL PATIENT - FOR LEFT SIDE SEE (B)(4). UPDATE 23 JULY 2014 - UPDATED KID AND REVISION SURGERY DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340437 TOTAL ASR ACET IMP SIZE 58 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 2767506

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention