BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFCSIGM FEMFLUTROD14X175MM7DEG

    MDR report key: 2605213 · Received June 8, 2012

    Report

    Report Number
    1818910-2012-12137
    Event Type
    Injury
    Date Received
    June 8, 2012
    Date of Event
    August 17, 2010
    Report Date
    August 21, 2011
    Manufacturer
    DEPUY RAYNHAM ¿ 1219655 
    Product Code
    JWH
    PMA / PMN Number
    K952830
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    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.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A COMPLAINT DATABASE SEARCH ON THE PROVIDED SMARTSET GHV GENTAMICIN 40G (PRODUCT CODE 545035500, LOT NUMBER 2980992) FOUND ADDITIONAL REPORTS. A PREVIOUS DHR REVIEW ((B)(4)) DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER RELATED INCIDENT(S) AGAINST THE REMAINING PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS BASED ON THE LACK OF THE PRODUCT TO EXAMINE. 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 THE PRODUCT BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. 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

    UPDATE 9/9/2015 - MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE CEMENT IS NOW BEING ADDED FOR THE GROSSLY LOOSE STEM. PAIN WAS ALSO INDICATED IN THE REVISION OPERATIVE NOTE. THE MEDICAL RECORDS ALSO INDICATE THERE WAS A PREVIOUS NON-HEALING FRACTURE OF THE UPPER FEMUR THAT WAS CABLED, THE DATE AND CAUSE OF THE FRACTURE IS UNKNOWN AT THIS TIME. THE COMPLAINT WAS UPDATED ON: 10/7/2015

    Description of Event or Problem · 1

    UPDATE 2/29/2016 MEDICAL RECORDS RECEIVED. MEDICAL RECORDS REVIEWED FOR MDR REPORTABILITY. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING INVESTIGATION. THE COMPLAINT WAS UPDATED ON: MAR 15, 2016.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE BOLT FAILED AND FRACTURED. UPDATE: (B)(6) 2011 - RECEIVED STICKER PAGES FROM THE LEGAL DEPARTMENT, WHICH INCLUDES PRODUCT CODE AND LOT INFORMATION. UPDATE: (B)(6) 2011 - REVISION OPERATIVE REPORT RECEIVED AND STATES DISASSOCIATION BETWEEN THE FEMORAL COMPONENT AND THE FEMORAL STEM, AS WELL AS THE BOLT CONNECTING THE TWO HAD BROKEN; THE FEMORAL COMPONENT WAS GROSSLY LOOSE AND WITH SUCH DISASSOCIATED FROM THE FEMORAL STEM. FEMORAL STEM AND FEMORAL COMPONENT ADDED TO COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFCSIGM FEMFLUTROD14X175MM7DEG STEM KNEE IMPLANT JWH DEPUY RAYNHAM ¿ 1219655  305675R

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention