BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS 3PEG MOD ROT PAT CEM SM+

    MDR report key: 3874454 · Received June 16, 2014

    Report

    Report Number
    1818910-2014-21047
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    May 28, 2014
    Report Date
    July 1, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    MBH
    PMA / PMN Number
    PP830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. PATIENT MEDICAL RECORDS AND X-RAYS WERE PROVIDED. REVIEW OF THE SUPPLIED INVESTIGATIONAL INPUTS CONFIRMED THE POLYETHYLENE COMPONENT HAD DISSOCIATED FROM THE METAL COMPONENT. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE ROOT CAUSE OF THE DEVICE DISASSOCIATION; HOWEVER, PROVIDED INFORMATION STATED THE DISASSOCIATION WAS A RESULT OF THE POLYETHYLENE COMPONENT WEAR. ADDITIONAL PROVIDED INFORMATION STATED THE SURGEON FELT THE DEVICE WEAR WAS NORMAL. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED.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

    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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: UPDATED PATIENT INITIALS, PATIENT DOB, PATIENT CODES, AND B4/G4 DATES; 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED BECAUSE THE PATELLA WAS WORN LATERALLY AND NO LONGER CONNECTED TO THE BASEPLATE. THE DOCTOR THOUGHT THE IMPLANT "LIVED A NORMAL LIFE AND DID IT'S JOB."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353435 LCS 3PEG MOD ROT PAT CEM SM+ KNEE PATELLAR COMPONENT MBH DEPUY ORTHOPAEDICS, INC. 1818910 WB8B11002

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention