BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR IMPLANT 50

    MDR report key: 2250722 · Received September 16, 2011

    Report

    Report Number
    1818910-2011-18284
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    September 12, 2011
    Report Date
    August 31, 2011
    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
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY. OTHER TEXT: NOT RETURNED.

    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).

    Additional Manufacturer Narrative · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGAL SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT ¿ ASR REVISION ASR XL ACETABULAR SYSTEM RIGHT HIP REASON(S) FOR REVISION: PAIN/ALVAL UPDATE AUG 18, 2017: EMAIL NOTIFICATION FROM KENNEDYS RECEIVED. THERE IS NO NEW INFORMATION ADDED THAT CHANGES THE MDR DECISION. UPDATED THE PRODUCT INFORMATION. THIS COMPLAINT WAS UPDATED ON: AUG 29, 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.

    Description of Event or Problem · 1

    THE PATIENT IS SCHEDULED FOR AN ASR REVISION TO ADDRESS PAIN ATTRIBUTED TO DISLOCATION, PSEUDOTUMOR, AND ALVAL.

    Description of Event or Problem · 1

    AUG 18, 2017: EMAIL NOTIFICATION FROM (B)(4) RECEIVED. THERE IS NO NEW INFORMATION ADDED THAT CHANGES THE MDR DECISION. UPDATED PRODUCT INFORMATION THIS COMPLAINT WAS UPDATED ON: AUG 29, 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR IMPLANT 50 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 8010379 2518092

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention