BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX50OD

    MDR report key: 3422124 · Received October 22, 2013

    Report

    Report Number
    1818910-2013-31115
    Event Type
    Injury
    Date Received
    October 22, 2013
    Date of Event
    March 25, 2013
    Report Date
    October 16, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    PMA / PMN Number
    K062426
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE AND/OR DHR REVIEW WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

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

    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. (B)(4).

    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.

    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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, AND LARGE AMOUNTS OF TOXIC COBALT CHROMIUM METAL ION PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE, AND BONE.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, AND LARGE AMOUNTS OF TOXIC COBALT CHROMIUM METAL ION PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE, AND BONE. UPDATE 1/28/2015 - DISC 209 PFS AND MEDICAL RECORDS RECEIVED. PFS IDENTIFIED PATIENT DOB, HEIGHT AND WEIGHT. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. UPDATE 2/1/2017, 02/09/1207- MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, A RADIOLOGY REPORT DATED (B)(6) 2013 INDICATED A FRACTURE OF THE LATERAL CORTEX OF THE PROXIMAL FEMORAL DIAPHYSIS. NO REVISION OPERATIVE NOTE HAS BEEN PROVIDED TO INDICATE WHEN/WHY THE FRACTURE OCCURED. CABLES WERE ALSO NOTED ON THE RADIOLOGY REPORT. AN UNKNOWN STEM WILL BE ADDED THIS TIME.

    Description of Event or Problem · 1

    UPDATE (B)(6) 2017 ¿ PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION SURGERY NOTES REPORTED PSEUDOTUMOR, METALLOSIS, OSTEOLYSIS, AND FRACTURE OF THE LATERAL CORTEX OF THE PROXIMAL FEMORAL DIAPHYSIS. THERE WAS NO MENTION OF LOOSENING DURING THE REVISION SURGERY NOTES. PART/LOT NUMBERS PROVIDED. THE COMPLAINT WAS UPDATED ON: (B)(6) 2017.

    Description of Event or Problem · 1

    UPDATE MAY 03, 2017 LEGAL MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS, THERE IS NO NEW INFORMATION. THIS COMPLAINT WAS UPDATED ON MAY 09, 2017.

    Description of Event or Problem · 1

    UPDATE MAY 14, 2017: LITIGATION RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PFS ALLEGES DIFFICULTY IN WALKING AND TROUBLE IN PERFORMING NORMAL DAILY ACTIVITIES. THIS COMPLAINT WAS UPDATED ON MAY 19, 2017.

    Description of Event or Problem · 1

    UPDATE JUN 22, 2017: LEGAL MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THERE IS NO NEW INFORMATION ADDED THAT CHANGES THE MDR DECISION. ADDED LABORATORY FINDING. THIS COMPLAINT WAS UPDATED ON: JUN 29, 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540517 PINNACLE MTL INS NEUT36IDX50OD METAL LINER KWA DEPUY ORTHOPAEDICS INC US 2394819

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention