BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMP RP INSERT STD+ 10MM

    MDR report key: 4582462 · Received March 9, 2015

    Report

    Report Number
    1818910-2015-15673
    Event Type
    Injury
    Date Received
    March 9, 2015
    Date of Event
    February 16, 2015
    Report Date
    February 17, 2015
    Manufacturer
    1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC
    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

    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. (B)(4).

    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 DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES ON THE PROVIDED PRODUCT AND LOT COMBINATION(S). 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

    REVISION TKR - PATIENT PRESENTED 2 YEARS POST ORIGINAL OPERATION WITH CONTINUED PAIN AND FFD OF 20 DEGREES. REMOVAL OF FEMORAL COMPONENT AND INSERT REQUIRED AND MORE DISTAL BONE REMOVED TO ADDRESS FFD. REVISION VARIANT LCS MODULAR FEMUR AND POSTERIOR AUGMENTS, AND SIMILAR INSERT REIMPLANTED. PATIENT HAD FULL EXTENSION ON THE TABLE FOLLOWING PROCEDURE. PATELLA ALSO RESURFACED DURING THE REVISION PROCEDURE. FFD LIKELY DUE TO SURGICAL ERROR INITIALLY OR POOR POST-OP REHABILITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161524 LCS COMP RP INSERT STD+ 10MM KNEE TIBIAL BEARING/INSERT NJL 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC 230945

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention