BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC*SIGMA/OV/DOME PAT 3PEG,35

    MDR report key: 4213879 · Received October 30, 2014

    Report

    Report Number
    1818910-2014-30918
    Event Type
    Injury
    Date Received
    October 30, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 13, 2014
    Manufacturer
    DEPUY IRELAND 9616671
    Product Code
    NJL
    PMA / PMN Number
    PP830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). 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

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. REVIEW OF THE DEVICE HISTORY RECORDS FOR ALL OF THE PRODUCTS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES BASED ON THE PROVIDED PRODUCT AND LOT COMBINATIONS. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. 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.

    Description of Event or Problem · 1

    LEFT KNEE REVISION PERFORMED ON (B)(6) 2014. PATELLA WAS REVISED DUE TO MAL-ALIGNMENT. PRIMARY LEFT TKR WAS PERFORMED ON (B)(6) 2010. PRIMARY OP RECORD AND PRE-OP X-RAY PHOTO ARE AVAILABLE. PATIENT INITIALS (B)(6)., MALE, DOB (B)(4) 1928. NO FURTHER PATIENT DEMOGRAPHICS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696612 PFC*SIGMA/OV/DOME PAT 3PEG,35 KNEE PATELLAR COMPONENT NJL DEPUY IRELAND 9616671 3085730

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention