BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM*STM STD,30NK 14X09X130

    MDR report key: 2922584 · Received January 18, 2013

    Report

    Report Number
    1818910-2013-01386
    Event Type
    Injury
    Date Received
    January 18, 2013
    Report Date
    December 20, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    JDI
    UDI-DI
    10603295170969
    PMA / PMN Number
    K851422
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATE: 12/20/2012- MEDICAL RECORDS AND PATIENT FACT SHEET RECEIVED. OPERATIVE NOTES INDICATED A FRACTURE; THEREFORE, A STEM HAS BEEN ADDED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. RECORDS ARE AVAILABLE ON THE L:\DRIVE IF NEEDED FOR FURTHER REVIEW. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL REPORTS FOR THE REPORTED PART AND LOT CODE COMBINATIONS. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE FOR THE UNKNOWN FEMORAL HEAD AND THE UNKNOWN STEM AS THE PRODUCT AND LOT CODES REQUIRED WERE NOT PROVIDED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. 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

    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

    THE INVESTIGATION IS ONGOING. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PATIENT SUFFERS FROM SEVERE PAIN, DISCOMFORT, AND INFLAMMATION. LITIGATION ALSO ALLEGES LARGE AMOUNTS OF TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE PLAINTIFFS BLOOD, TISSUE, AND BONE. **UPDATE** (B)(4) 2012 - LITIGATION PAPERS RECEIVED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION.

    Description of Event or Problem · 1

    UPDATE (B)(6) 2015 - PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE PRIMARY NOTE INDICATED THE PATIENT DID SUSTAIN A TROCHANTERIC FRACTURE. IT IS UNCLEAR WHAT CAUSED THE FRACTURE, BUT IT WAS AFTER THE SROM STEM/SLEEVE WERE PLACED. AN UNKNOWN SROM SLEEVE IS BEING ADDED. THE FRACTURE RESULTED IN A TROCHANTERIC OSTEOTOMY. NO LABS WERE PROVIDED FOR THE ALLEGED HIGH METAL IONS. POST-OPERATIVER X-RAYS INDICATED A MALPOSITIONED STEM. NO PART/LOT HAS BEEN PROVIDED FOR THE HEAD, STEM, OR SLEEVE. THE COMPLAINT WAS UPDATED ON: (B)(4) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28043 S-ROM*STM STD,30NK 14X09X130 S-ROM HIP SYSTEM : HIP FEMORAL STEM JDI DEPUY ORTHOPAEDICS, INC. 1818910 1953945 10603295170969

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other