BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 53

    MDR report key: 2140955 · Received June 21, 2011

    Report

    Report Number
    1818910-2011-08188
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    April 2, 2010
    Report Date
    March 31, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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: (B)(6) 2008; DOR: (B)(6) 2010. **UPDATE** (B)(6) 2011 (RECEIVED BY DEPUY (B)(4) ON (B)(4) 2011) - MEDICAL RECORDS WERE RECEIVED. THE REVISION OPERATIVE REPORT INDICATES CHRONIC HIP SYNOVITIS. (RIGHT 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.

    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

    PRODUCT COMPLAINT # (B)(4). 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). 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). INVESTIGATION SUMMARY: 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. THE INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS WAS CONDUCTED UNDER MDD CAPA- 001226. ONGOING POST MARKET SURVEILLANCE IS CONDUCTED PER OUR PROCEDURES FOR THIS PRODUCT. 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 CONTACTED BROADSPIRE TO INITIATE CLAIM. MEDICAL RECORDS WERE RECEIVED. THE REVISION OPERATIVE REPORT INDICATES CHRONIC HIP SYNOVITIS.

    Description of Event or Problem · 1

    ASR LITIGATION RECORDS RECEIVED ALLEGING ELEVATED BLOOD HEAVY METAL ION LEVELS, INJURY, PAIN AND SUFFERING.

    Description of Event or Problem · 1

    MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS CHRONIC SEROMA OF THE RIGHT HIP AND CHRONIC HIP SYNOVITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 53 87KWA KWA DEPUY ORTHOPAEDICS, INC. 1818910 NA 2598878

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention