BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR HIP

    MDR report key: 1931183 · Received December 15, 2010

    Report

    Report Number
    1818910-2010-10088
    Event Type
    Injury
    Date Received
    December 15, 2010
    Report Date
    November 18, 2010
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    MM 40-06
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A LOT SPECIFIC COMPLAINT DATABASE SEARCH AND/OR A REVIEW OF DEVICE HISTORY RECORDS WERE NOT POSSIBLE AS THE NECESSARY PRODUCT/LOT CODE COMBINATION WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. ALTHOUGH THE ROOT CAUSE CANNOT BE DETERMINED, IT IS KNOWN THAT THE ASR PLATFORM WAS VOLUNTARILY RECALLED IN 8/2010 FOLLOWING AN HHE (HEALTH HAZARD EVAL). FURTHER ANALYSIS REGARDING THE ASR PRODUCT FAMILY WILL BE DOCUMENTED, AS DETERMINED PERTINENT, IN WWCAPA (B)(4). BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR FURTHER CORRECTIVE ACTION IS NOT INDICATED AT THIS TIME. 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

    UPDATE: (B)(6) 2010 - MEDICAL RECORDS WERE RECEIVED BY (B)(6). MEDICAL RECORDS INDICATE THAT THE PATIENT WILL BE REVISED (B)(6) 2011 DUE TO COMPLAINTS OF PAIN. PRODUCT AND LOT NUMBERS WERE IDENTIFIED. DOI: (B)(6) 2009 (LEFT SIDE). UPDATE: (B)(6) 2011 - THE REVISION SURGERY WAS REPORTED BY THE SALES REPRESENTATIVE. THE PATIENT WAS REVISED TO ADDRESS PAIN. FINDINGS SHOWED ABNORMAL TISSUE CHANGES AND SIGNS OF AN ADVERSE RESPONSE. CUP WAS REMOVED AND SHOWED NO SIGNS OF BONY INGROWTH. DOR: (B)(6) 2011 (LEFT SIDE). 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.

    Description of Event or Problem · 1

    PT CONTACTED BROADSPIRE TO INITIATE CLAIM. PT REPORTED REVISION SURGERY. REASON FOR REVISION IS UNK. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR HIP ASR 300 SPIKED CUP KWA DEPUY INTERNATIONAL, LTD. NA 2826569

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention