BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 56

    MDR report key: 2232381 · Received August 18, 2011

    Report

    Report Number
    1818910-2011-15744
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    July 25, 2011
    Report Date
    October 3, 2016
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    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 (B)(4) 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 ADD'L INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    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.

    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. REF. WWCAPA (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 CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THE INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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

    PT WAS REVISED TO ADDRESS ACETABULAR LOOSENING. THE CUP HAD ROTATED.

    Description of Event or Problem · 1

    UPDATE - 10/03/2016 MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED,THE MEDICAL RECORDS REPORT PAIN AND STIFFNESS PART NUMBER FOR HEAD PROVIDED.

    Description of Event or Problem · 1

    ON 1/9/2017 MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISING SURGEON NOTED IN THE SURGICAL INDICATIONS THAT THE PATIENT HAD AN ELEVATED COBALT ION LEVEL OF 17 PPB, ALTHOUGH CHROMIUM THE LEVEL WERE NORMAL. ELEVATED METAL IONS HARM ADDED TO COMPLAINT. ASR SLEEVE AND STEM ADDED TO COMPLAINT. IMPLANT STICKERS ARE AVAILABLE WITHIN THE RECORD BUT ARE FOR INTERNATIONALLY DISTRIBUTED PRODUCTS NEVER SOLD IN THE USA. ACCESS TO MANUFACTURING LOTS, DATES AND POST-MARKET CODES ARE STILL PENDING FOR THOSE PRODUCTS, AND THE COMPLAINT WILL BE UPDATED WHEN/IF THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    UPDATE OCT 2, 2017: MEDICAL RECORD RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR THE MDR REPORTABILITY, IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, REVISION NOTES REPORTED SEVERAL AREAS WERE CYSTIC. PRODUCT CODES AND LOT NUMBERS UPDATED. THIS COMPLAINT WAS UPDATED ON OCT 23, 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 56 87KWA KWA DEPUY INTERNATIONAL LTD. 8010379 NA 1184624

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention