BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRI-LOCK BPS SZ 4 HI OFFSET

    MDR report key: 5200934 · Received November 4, 2015

    Report

    Report Number
    1818910-2015-34405
    Event Type
    Injury
    Date Received
    November 4, 2015
    Date of Event
    October 22, 2015
    Report Date
    October 22, 2015
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK073570
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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. SEE REPORT FOR ANY PRODUCT INFORMATION RECEIVED. DEPUY SYNTHES HAS BEEN INFORMED THAT THE CATALOG NUMBER AND LOT NUMBER IS NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    UPDATE REC'D 1/14/2016: LITIGAITON PAPERS RECEIVED. PART/LOT WILL BE UPDATED. THIS COMPLAINT WAS UPDATED ON: 1/21/2016. BRAND NAME: TRI-LOCK BPS SZ 4 HI OFFSET. ADD'L PROCODE: KWA. PART NUMBER: 101214040. LOT NUMBER:D4FBL1. PMA 510(K): K073570. DEVICE MFR DATE: 9/29/2009. (B)(4). MANUFACTURING FACILITY: (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 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

    PATIENT WAS REVISED DUE TO SKIN RASH WITH ELEVATED CHROMIUM LEVELS.

    Description of Event or Problem · 1

    UPDATE 12/23/2015: LITIGATION PAPERS RECEIVED. IN ADDITIONAL TO WHAT THE PATIENT WAS REVISED FOR, THE PATIENT ALSO ALLEGES PAIN, STIFFNESS, AND WEAKNESS. A DOI WAS PROVIDED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING INVESTIGATION. THIS COMPLAINT WAS UPDATED ON: 1/8/2016.

    Description of Event or Problem · 1

    UPDATE REC'D 1/14/2016: LITIGAITON PAPERS RECEIVED. PART/LOT WILL BE UPDATED.THIS COMPLAINT WAS UPDATED ON: 1/21/2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731107 TRI-LOCK BPS SZ 4 HI OFFSET HIP FEMORAL STEM/SLEEVE KWA 1818910 DEPUY ORTHOPAEDICS, INC. D4FBL1

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention