BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 50

    MDR report key: 4090717 · Received September 15, 2014

    Report

    Report Number
    1818910-2014-28038
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    January 7, 2013
    Report Date
    December 1, 2014
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.(B)(4). DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    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. 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. 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE PATIENT WAS REVISED TO ADDRESS ASEPTIC LOOSENING OF THE LEFT FEMORAL COMPONENT WITH PAINFUL HETEROTOPIC OSSIFICATION. EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. MEDICAL RECORDS INDICATE THE PATIENT WAS REVISED TO ADDRESS ASEPTIC LOOSENING OF THE LEFT FEMORAL COMPONENT WITH PAINFUL HETEROTOPIC OSSIFICATION. THE ASR DEVICES ARE CONSIDERED NON-CONTRIBUTING TO THIS REPORT AND HAVE BEEN DISCONTINUED/OBSOLETED AND WILL NOT BE INVESTIGATED FURTHER. A SEARCH OF THE COMPLAINTS DATABASES AGAINST THE PROVIDED FEMORAL STEM PRODUCT/LOT CODE COMBINATION FINDS NO OTHER REPORTS. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED.

    Description of Event or Problem · 1

    UPDATE REC'D 9/15/2014 - MEDICAL RECORDS RECEIVED. PATIENT REVISED TO ADDRESS HETERTOPIC OSSIFICATION. UPON REVISION, SUBSIDENCE AND LOOSENING OF THE FEMORAL COMPONENT, AND NO SYMPTOMS OF METAL-ON-METAL DISEASES WERE NOTED. THE STEM IS BEING ADDED TO THE COMPLAINT. THIS COMPLAINT WAS UPDATED ON: 10/01/2014.

    Description of Event or Problem · 1

    LEGAL CLAIM RECEIVED. UPDATE REC'D (B)(4) 2014- LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES PAIN, DISFIGUREMENT, AND PERMANENT PHYSICAL INJURIES. THE INVOICE WAS LOCATED, WHICH UPDATED PART/LOT. DOR IS UPDATED. THE EXISTING MDR DECISION HAS BEEN REVERSED AND THE ACETABULAR CUP AND FEMORAL HEAD HAVE BEEN REPORTED. THE COMPLAINT WAS UPDATED ON: (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570201 ASR ACETABULAR CUPS 50 HIP ACETABULAR CUP KWA DEPUY INTL., LTD. - 8010379 2519127

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention