BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 52

    MDR report key: 2802061 · Received October 23, 2012

    Report

    Report Number
    1818910-2012-23846
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    January 24, 2012
    Report Date
    March 20, 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

    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

    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

    DEPUY STILL 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 XL ACETABULAR SYSTEM (RIGHT). REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION.

    Description of Event or Problem · 1

    ADDITIONAL REASON FOR REVISION: METALLOSIS.

    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 RECOMMENDED REVISION - BILATERAL UPDATE: ADDED HIP TO BE REVISED, SYSTEM DESC', PRODUCTS. DATE OF REVISION AND REASON FOR REVISION - RECEIVED 03 OCT 2012. ASR XL ACETABULAR SYSTEM (RIGHT); REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION RECEIVED CONFIRMATION THAT DINT (B)(4)IS A DUPLICATION OF THIS COMPLAINT, ANY CONTRASTING INFORMATION HAS BEEN TRANSFERRED OVER TO THIS DINT - (B)(4) 2012. REASON(S) FOR REVISION: PAIN. THIS PATIENT IS BI-LATERAL, THIS DINT IS FOR THE RIGHT HIP. FOR THE LEFT HIP REVISION PLEASE SEE (B)(4). UPDATE RECEIVED: 26TH SEPTEMBER 2013 - ADDED FURTHER REVISION REASON: METALLOSIS, CROSS REFERENCED, ADDED SURGEONS FORENAME: PROF GEORGE AND ATTACHED DOCUMENTS. PLEASE NOTE THE STEM HAS NOT BEEN REPORTED ON THIS COM AS PREVIOUSLY WAS ON THE INITIAL DINT AS THE REVISION SURGERY NOTES ON THE END OF THE SURGEON CONFIRMATION FORM ADVISE THE STEM WAS NOT REVISED. UPDATE - STEM RECEIVED ON CLAIMSUITE, ADDED STEM, FILLED OUT ALL MW FIELDS, MANUFACTURING AND EXPIRY DATES. TAKEN FROM CLAIMSUITE DATED 20TH MARCH 2015.

    Description of Event or Problem · 1

    REASON(S) FOR REVISION: PAIN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL ASR ACET IMP SIZE 52 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 2435434

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention