BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MBT CEM TIBIAL TRAY SZ3

    MDR report key: 6551296 · Received May 8, 2017

    Report

    Report Number
    1818910-2017-17740
    Event Type
    Injury
    Date Received
    May 8, 2017
    Date of Event
    April 13, 2017
    Report Date
    April 13, 2017
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    NJL
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # ==> PC-000101858 INVESTIGATION SUMMARY ==> NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. DEVICE HISTORY LOT ==> NULL DEVICE HISTORY BATCH ==> NULL DEVICE HISTORY REVIEW ==> NULL 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

    REVISION TKR PERFORMED (B)(6) 2017 . PRIMARY IMPLANT DATE WAS (B)(6) 2003. REASON FOR REVISION - THE PATIENT COMPLAINED OF ANTERIOR MEDIAL KNEE PAIN. DURING THE SURGERY, THE APG INSERT AND GUIDE WERE REMOVED. THE FEMORAL COMPONENT WAS CHECKED TO SEE IF IT WAS LOOSE AND WAS THEN REMOVED. A 12.5MM LCS RP INSERT WAS INSERTED AND AN LCS STD CEMENTED FEMUR WAS CEMENTED INTO PLACE. THE PATELLA WAS RESURFACED AND AN ALL POLY STD PATELLA WAS CEMENTED INTO PLACE. FEMALE PATIENT. AE TO PATIENT REVISION SURGERY PERFORMED. NO DELAYS TO SURGERY. THE REPORTED EVENT HAS BEEN EVALUATED AND WILL BE MONITORED. 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. 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

    THIS COMPLAINT IS UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THE INVESTIGATION ONCE IT HAS BEEN COMPLETED. (B)(4). 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

    COMPLAINT DESCRIPTION: REVISION TKR PERFORMED AT (B)(6) (B)(6) 2017 . PRIMARY IMPLANT DATE WAS (B)(6) 2003. REASON FOR REVISION - THE PATIENT COMPLAINED OF ANTERIOR MEDIAL KNEE PAIN. DURING THE SURGERY, THE APG INSERT AND GUIDE WERE REMOVED. THE FEMORAL COMPONENT WAS CHECKED TO SEE IF IT WAS LOOSE AND WAS THEN REMOVED. A 12.5MM LCS RP INSERT WAS INSERTED AND AN LCS STD CEMENTED FEMUR WAS CEMENTED INTO PLACE. THE PATELLA WAS RESURFACED AND AN ALL POLY STD PATELLA WAS CEMENTED INTO PLACE. FEMALE PATIENT. AE TO PATIENT REVISION SURGERY PERFORMED. NO DELAYS TO SURGERY. / / INVESTIGATION METHOD: INVESTIGATION METHODS: WAS PATIENT AFFECTED: YES. DEVICE HISTORY REVIEWED: YES. LOT TRACE OBTAINED: NO. COMPLAINTS DATABASE SEARCHED: YES. PRODUCT CHECKED: NO. LABEL CHECKED: NO. PRODUCT PULLED FROM STOCK FOR INSPECTION: NO INVESTIGATION RESULTS: THE COMPLAINT WAS RECEIVED ON MAR 08, 2017. A REVIEW OF COMPLAINT DATABASES IDENTIFIED PREVIOUS COMPLAINTS RECEIVED FOR PAIN HOWEVER A LOT SPECIFIC DID NOT IDENTIFY ANY OTHER COMPLAINTS. DHR REVIEW PRODUCT CODE 129404040, WORK ORDER 1118600 WAS MANUFACTURED ON (B)(6) 2003. 10 PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. PRODUCT CODE 129406020, WORK ORDER 1022935 WAS MANUFACTURED ON (B)(6) 2002. 20 PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. PRODUCT CODE 129431130, WORK ORDER 1130201 WAS MANUFACTURED ON (B)(6) 2003. 18 PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. - WITHOUT THE PHYSICAL COMPLAINT SAMPLE(S) ASSOCIATED WITH THIS REPORT, IT WAS NOT POSSIBLE TO DETERMINE IF THE DEVICE(S) FAILED TO MEET SPECIFICATION(S) AT THE TIME IT WAS RELEASED FOR DISTRIBUTION. - THE DEVICE(S) ASSOCIATED WITH THIS EVENT WERE USED IN THE TREATMENT OF THE PATIENT AS PRESCRIBED BY THE PRESIDING SURGEON. - FROM THE EVENT INFORMATION RECEIVED, IT WAS NOT POSSIBLE TO DETERMINE THE RELATIONSHIP OF THE DEVICE TO THE REPORTED EVENT. / / INVESTIGATION SUMMARY: CONCLUSION AND JUSTIFICATION STATUS: THE COMPLAINT STATES REVISION TKR PERFORMED AT CALVARY WAKEFIELD 13.04.2017 . PRIMARY IMPLANT DATE WAS (B)(6) 2003. REASON FOR REVISION - THE PATIENT COMPLAINED OF ANTERIOR MEDIAL KNEE PAIN. DURING THE SURGERY, THE APG INSERT AND GUIDE WERE REMOVED. THE FEMORAL COMPONENT WAS CHECKED TO SEE IF IT WAS LOOSE AND WAS THEN REMOVED. A 12.5MM LCS RP INSERT WAS INSERTED AND AN LCS STD CEMENTED FEMUR WAS CEMENTED INTO PLACE. THE PATELLA WAS RESURFACED AND AN ALL POLY STD PATELLA WAS CEMENTED INTO PLACE. FEMALE PATIENT. AE TO PATIENT REVISION SURGERY PERFORMED. NO DELAYS TO SURGERY. A REVIEW OF MANUFACTURING RECORDS AND COMPLAINT DATABASES DID NOT IDENTIFY ANY ANOMALIES. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION; ENTERED INTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. IF FURTHER INFORMATION IS RECEIVED THE COMPLAINT SHALL BE REOPENED AND INVESTIGATED FURTHER. POST MARKET SURVEILLANCE IS PER SEP.

    Description of Event or Problem · 1

    REASON FOR REVISION - THE PATIENT COMPLAINED OF ANTERIOR MEDIAL KNEE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332394 MBT CEM TIBIAL TRAY SZ3 KNEE TIBIAL TRAY NJL DEPUY ORTHOPAEDICS INC US 1130201

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention