BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIG RPF CEM FEM SZ 4 RT

    MDR report key: 4092502 · Received September 16, 2014

    Report

    Report Number
    1818910-2014-28182
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 29, 2014
    Manufacturer
    DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS1219655
    Product Code
    NJL
    PMA / PMN Number
    PP830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SEARCH OF THE COMPLAINTS DATABASE IDENTIFIED NO PREVIOUS COMPLAINTS INVOLVING THE LOT NUMBERS OF THE PRODUCTS INVOLVED IN THIS COMPLAINT. A REVIEW OF THE MANUFACTURING RECORDS FOR LOT NUMBERS CT8DL4000, 2619679 AND C16HX4000 FOUND NO ANOMALIES THAT WOULD HAVE CAUSED THE REPORTED INCIDENT. 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    DATE OF BIRTH ((B)(6) 1941), IMPLANT DATE ((B)(6) 2008), PMA/510(K) # (P830055), MANUFACTURE DATE (MAY 22, 2008), BRAND NAME (PFC SIG RPF CEM FEM SZ 4 RT), DEVICE PRODUCT CODE (NJL), MANUFACTURER NAME/ADDRESS ((B)(4)), CATALOG #/LOT # (950025; LOT# CT8DL4000). THE INVESTIGATION IS ONGOING. 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. (B)(4).

    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

    THE COMPLAINT REMAINS IN 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

    PFC RPF FEMUR / DUOFIX TIBIA REVISION PERFORMED ON (B)(6) 2014 AT (B)(6) HOSPITAL. REASON FOR REVISION : PAIN. ON EXPOSURE, IT WAS DEEMED THE FEMORAL COMPONENT WAS MICROSCOPICALLY LOOSE. THE FEMUR CAME AWAY WITHOUT ANY CEMENT, ALL OF WHICH WAS LEFT WELL FIXED TO THE DISTAL FEMUR. IT APPEARED THAT THERE WAS AN ISSUE WITH THE CEMENT/PROSTHESIS INTERFACE. THE DUOFIX TIBIA APPEARED WELL INTEGRATED. THE SURGEON IN THIS CASE CHOSE TO REVISE USING A ZIMMER LCCK. THE REVISION WAS STRAIGHT FORWARD WITH A VERY SATISFACTORY RESULT. REP TO CONFIRM WHETHER THE EXPLANTS WILL BE AVAILABLE FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572958 PFC SIG RPF CEM FEM SZ 4 RT KNEE FEMORAL COMPONENT NJL DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS1219655 CT8DL4000

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention