BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRI-LOCK BPS SZ 7 STD OFFSET

    MDR report key: 5201358 · Received November 4, 2015

    Report

    Report Number
    1818910-2015-34421
    Event Type
    Injury
    Date Received
    November 4, 2015
    Date of Event
    October 13, 2015
    Report Date
    October 19, 2015
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC
    Product Code
    KWA
    PMA / PMN Number
    PK073570
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THIS COMPLAINT IS THE SUBJECT OF LITIGATION OR A LEGAL CLAIM AND CURRENTLY COMPLETE PRODUCT DETAIL IS NOT AVAILABLE AT THIS TIME. A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: MANUFACTURING FACILITY: DEPUY ORTHOPAEDICS, INC. PATIENT AGE: (B)(4). UPDATE 2/19/16 MEDICAL RECORDS RECEIVED. MEDICAL RECORDS REVIEWED FOR MDR REPORTABILITY. PART/LOT UPDATED. THE COMPLAINT WAS UPDATED ON: MAR 2, 2016. (B)(4). BRAND NAME: TRI-LOCK BPS SZ 7 STD OFFSET. DEVICE PRO CODE: FDA CODE: KWA. PART NUMBER: 101204070. LOT NUMBER: CX7CC1000. THE 510K #: K073570 DEVICE MFR DATE: 6/17/2008. (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 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. (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

    LITIGATION ALLEGES PATIENT SUFFERS FROM PAIN. UPDATE (B)(6) 2015 - LITIGATION RECEIVED. LITIGATION ALLEGES PATIENT SUFFERS FROM ELEVATED COBALT CHROMIUM METAL IONS. THE SLEEVE AND STEM ARE NOW BEING REPORTED.

    Description of Event or Problem · 1

    UPDATE 2/19/16 MEDICAL RECORDS RECEIVED. MEDICAL RECORDS REVIEWED FOR MDR REPORTABILITY. PART/LOT UPDATED. THE COMPLAINT WAS UPDATED ON: MAR 2, 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730912 TRI-LOCK BPS SZ 7 STD OFFSET HIP FEMORAL STEM/SLEEVE KWA 1818910 DEPUY ORTHOPAEDICS, INC CX7CC1000

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention