BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 56

    MDR report key: 2770248 · Received October 3, 2012

    Report

    Report Number
    1818910-2012-76235
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    April 23, 2012
    Report Date
    April 27, 2015
    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

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    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 THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY.

    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.

    Description of Event or Problem · 1

    ASR REVISION; RIGHT; ASR XL; REASON(S) FOR REVISION: UNKNOWN.

    Description of Event or Problem · 1

    REASON FOR REVISION: PAIN, ELEVATED METAL IONS.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT - ASR REVISION. RIGHT. ASR XL. REASON(S) FOR REVISION: UNKNOWN. BI-LATERAL. FOR LEFT HIP SEE (B)(4). INCORRECT LOT NUMBER PROVIDED FOR THE HEAD (2711849). REQUESTED SEPARATE REVISION DATES VIA EMAIL. UPDATE RECEIVED 15TH AUGUST, PARTIAL INFORMATION RECEIVED 6TH AUGUST. REASONS FOR REVISION ADDED. REASON(S) FOR REVISION: PAIN, HIGH COBALT AND CHROMIUM BLOOD ION LEVELS. UPDATE RECEIVED: 30TH MAY 2014 - MARKED AS LEGAL, ADDED (B)(6) REFERENCE NUMBER, FILLED MAPPED TO MW FIELDS AND ADDED HOSPITALS: (B)(6).

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT - ASR REVISION, RIGHT, ASR XL, REASON(S) FOR REVISION: UNKNOWN. BI-LATERAL. FOR LEFT HIP SEE (B)(4) (COM (B)(4)). INCORRECT LOT NUMBER PROVIDED FOR THE HEAD (2711849). REQUESTED SEPARATE REVISION DATES VIA EMAIL UPDATE RECEIVED (B)(6), PARTIAL INFORMATION RECEIVED (B)(6). REASONS FOR REVISION ADDED. REASON(S) FOR REVISION: PAIN, HIGH COBALT AND CHROMIUM BLOOD ION LEVELS UPDATE RECEIVED: (B)(6) 2014 - MARKED AS LEGAL, ADDED (B)(6) REFERENCE NUMBER, FILLED MAPPED TO MW FIELDS AND ADDED HOSPITALS: (B)(6) HOSPITAL / (B)(6). UPDATE - ADDED STEM DETAILS, LOT NUMBER AND MANUFACTURING DATE FOR HEAD, ALL EXPIRY DATES FOR ALL PRODUCTS. TAKEN FROM CLAIMSUITE DATED (B)(6) 2015. HEAD LOT - 2771849.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL ASR ACET IMP SIZE 56 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 2611813

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention