BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC*SIGMA/RD/DOME PAT 3PEG,32

    MDR report key: 3094061 · Received May 6, 2013

    Report

    Report Number
    1818910-2013-16578
    Event Type
    Injury
    Date Received
    May 6, 2013
    Report Date
    May 7, 2013
    Manufacturer
    9616671 DEPUY (IRELAND)
    Product Code
    JWH
    PMA / PMN Number
    PK884796
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT REMAINS IMPLANTED. NO REVISION SURGERY HAS BEEN REPORTED. THE INITIAL REPORTING STATED RADIOGRAPHIC INFORMATION WAS NOT AVAILABLE FOR REVIEW. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. 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 AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION 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

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

    Description of Event or Problem · 1

    CLINICAL REPORT STATES THE PATIENT HAD PERIPATELLAR CREPITUS THAT WAS PAINFUL. TREATED WITH AN ARTHROSCOPIC SYNOVECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196582 PFC*SIGMA/RD/DOME PAT 3PEG,32 PATELLA JWH 9616671 DEPUY (IRELAND) 2416246

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention