BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR HIP

    MDR report key: 1931254 · Received December 15, 2010

    Report

    Report Number
    1818910-2010-10073
    Event Type
    Injury
    Date Received
    December 15, 2010
    Report Date
    August 18, 2014
    Manufacturer
    DEPUY INT'L., LTD.
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT STATES: PATIENT CONTACTED BROADSPIRE TO INITIATE CLAIM. PATIENT REPORTED REVISION SURGERY. REASON FOR REVISION IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. DOI: UNKNOWN; DOR: (B)(6) 2011. **UPDATE** (B)(6) 2011 - THE REVISION SURGERY WAS REPORTED BY THE SALES REP. THE PATIENT WAS REVISED TO ADDRESS HIP PAIN. DOI: UNK; DOR: (B)(6) 2011 (LEFT SIDE). PRODUCT/LOT NUMBERS WERE IDENTIFIED. **UPDATE**(B)(6) 2011; DOI: (B)(6) 2009 AS INDICATED BY MEDICAL RECORDS. NO ADDITIONAL INFORMATION INCLUDED THAT WOULD CHANGE THE INVESTIGATIVE FINDINGS. 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.

    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 AUGUST OF 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

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    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

    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 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 STILL CONSIDERS THIS COMPLAINT CLOSED.

    Description of Event or Problem · 1

    UPDATE 12/23/2013 - LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES LOOSENING AND INFECTION. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: 01/09/2014.

    Description of Event or Problem · 1

    PATIENT CONTACTED (B)(4) TO INITIATE CLAIM. PATIENT REPORTED REVISION SURGERY. REASON FOR REVISION IS UNK. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    UPDATE (B)(4) 2013 - CLINICAL REPORT WAS RECEIVED. THE PATIENT WAS ALSO REVISED TO ADDRESS INCREASED COBALT LEVELS. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR HIP TOTAL HIP REPLACEMENT KWA DEPUY INT'L., LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention