BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 52

    MDR report key: 2122840 · Received June 3, 2011

    Report

    Report Number
    1818910-2011-09936
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    July 16, 2018
    Report Date
    May 6, 2011
    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
    VA, US
    Reporter Occupation
    ATTORNEY

    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.

    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.

    Additional Manufacturer Narrative · 1

    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

    (B)(4). INVESTIGATION SUMMARY : THIS HIP REPLACEMENT PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET AND THE PRODUCT CODES ARE NOW CONSIDERED INACTIVE. DEPUY CONSIDERS THE INVESTIGATION CLOSED. 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.

    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.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED FOR AN UNKNOWN REASON. PATIENT HAD AN S-ROM FEMORAL STEM WITH AN ASR CUP. THE SURGEON REMOVED THE HEAD BALL AND CUP, IMPLANTED A BIOMET CUP/LINER AND USED A DEPUY SYNTHES HEAD BALL TO MATCH THE S-ROM 11/13 TAPER. DOI: (B)(6) 2009 ; DOR: 07/16/2018 ; LEFT HIP.

    Description of Event or Problem · 1

    MEDICAL RECORDS AND IMPLANT STICKER SHEETS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS LEFT HIP CHROMIUM AND COBALT TOXICITY WITH PAIN. IT WAS INDICATED THAT THE LEVELS WERE IN THE 50S. ACETABULAR COMPONENTS WERE NOTED TO BE VERY VERTICAL DURING ONE OF THE PRE-OPERATION VISITS.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE, ON OR ABOUT (B)(6) 2009 TO THE PRESENT, PATIENT SUFFERED THE FOLLOWING PERSONAL AND ECONOMIC INJURY(IES) AS A RESULT OF THE IMPLANTATION OF THE ASR HIP IMPLANT: COBALT AND/OR CHROMIUM POISONING, PAIN, CRACKING AND POPPING IN THE LEFT HIP; CONSTANT PAIN, INABILITY TO LEAD A NORMAL LIFE, POSSIBLE REVISION SURGERY, NUMEROUS FOLLOW-UP DOCTOR VISITS, ANXIETY, FEAR AND OTHER EMOTIONAL DAMAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 52 ACETABULAR CUP HIP IMPLANT KWA DEPUY INTERNATIONAL LTD. 8010379 NA 2876232

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention NA.