BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET GMV 40G US EO

    MDR report key: 7536737 · Received May 23, 2018

    Report

    Report Number
    1818910-2018-60309
    Event Type
    Injury
    Date Received
    May 23, 2018
    Date of Event
    April 26, 2018
    Report Date
    April 25, 2018
    Manufacturer
    DEPUY CMW - 9610921
    Product Code
    MBB
    UDI-DI
    10603295174295
    PMA / PMN Number
    K081163
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H6 CLINICAL CODE: APPROPRIATE TERM / CODE NOT AVAILABLE (E2402) IS USED TO CAPTURE BONE INJURY (E20). DMF# - 13704 , TRADE NAME ¿ GENTAMICIN SULPHATE , ACTIVE INGREDIENT(S) ¿ GENTAMICIN SULPHATE , DOSAGE FORM - POWDER , STRENGTH ¿ 1.0G ACTIVE IN OUR CEMENTS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. E3 INITIAL REPORTER OCCUPATION: LAWYER.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. PER INTERNAL PROCEDURES, THE EVENT INFORMATION AND ANY INVESTIGATIONAL INPUTS RECEIVED AS PART OF REQUIRED FOLLOW UP WERE REVIEWED. FOR THIS INVESTIGATION, NO IMMEDIATE ACTION WAS REQUIRED AS NO ALLEGED DEFICIENCY WITH THE DEVICE(S) WAS IDENTIFIED. MONITOR ¿ EXEMPT PER WI-7915 - KNOWN POSSIBLE COMPLICATION OF JOINT REPLACEMENT SURGERY NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. IN ORDER TO DETERMINE IF A LOT RELATED ISSUE WAS POSSIBLE, A WORLDWIDE COMPLAINT DATABASE SEARCH WAS PERFORMED. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO ADDITIONAL RELATED REPORTS AGAINST THE PROVIDED PRODUCT CODE/LOT CODE COMBINATION(S). BASED ON THE INABILITY TO FIND ANY ADDITIONAL RELATED REPORTS AGAINST THE PROVIDED PRODUCT CODE/LOT CODE COMBINATION(S) IT IS REASONABLE TO CONCLUDE THAT THERE ARE NO ANOMALIES WITH REGARD TO MANUFACTURING OR INSPECTION CONTAINED IN THE DEVICE HISTORY RECORDS THAT WOULD CONTRIBUTE TO THE REPORTED EVENT. THE REPORTED EVENT IS CONSIDERED ONE OF THE POSSIBLE COMPLICATIONS OF JOINT REPLACEMENT. INVESTIGATIONAL INPUTS WERE REQUESTED AS INDICATED PER INTERNAL PROCEDURES FOR THIS FAILURE MODE. THE COMPLAINT INFORMATION PROVIDED HAS BEEN REVIEWED FOR COMPLAINT CODING, MEDICAL DEVICE REPORTING, AND OTHER DATA REQUIRED BY THE COMPLAINT SYSTEM. FOLLOW-UP FOR ADDITIONAL EVENT INFORMATION, IF APPLICABLE, WAS CONDUCTED UTILIZING WORK INSTRUCTION WI-7915 APPENDIX A. 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. NO PRODUCT CONTRIBUTION TO THE REPORTED EVENT WAS IDENTIFIED. NO INFORMATION RECEIVED WITH THIS INDIVIDUAL COMPLAINT INDICATED THAT A BROADER INVESTIGATION OR CORRECTIVE ACTION WAS NECESSARY. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT : A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON (B)(4). 3 UNRELATED NON-CONFORMANCES ON THIS LOT NUMBER. FINAL MICRO AND STERILITY TESTS PASSED.

    Description of Event or Problem · 0

    PATIENT RECEIVED A RIGHT PRIMARY ATTUNE TKA TO TREAT OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT RECEIVED A RIGHT KNEE REVISION TO TIBIAL TRAY LOOSENING. THE FEMORAL COMPONENT WAS WELL-FIXED AND RETAINED. THE TIBIAL TRAY WAS LOOSENED AND DEBONDED AT THE CEMENT TO IMPLANT INTERFACE AND REVISED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. PATELLA WAS RETAINED. THE PATIENT WAS REVISED WITH A DEPUY REVISION CONSTRUCT UTILIZING DEPUY CEMENT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2017, DOR: (B)(6) 2017, RIGHT KNEE.

    Additional Manufacturer Narrative · 1

    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

    PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY 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.

    Description of Event or Problem · 1

    DER STATES THAT THE TIBIAL TRAY WAS LOOSE AND WAS REMOVED WITH NO CEMENT ON THE UNDERSIDE OF THE IMPLANT. ALL THE CEMENT WAS STILL ATTACHED TO THE PROXIMAL TIBIAL BONE. THE CEMENT USED WAS THE DEPUY GMV. THE SURGEON COMMENTED THAT HE FELT THE PATIENT HAD REALLY POOR BONE QUALITY SO HE WAS SURPRISED WHEN HE FOUND ALL THE CEMENT ATTACHED TO THE TIBIAL BONE AND BONE TO THE IMPLANT. I WILL BE RETURNING BOTH THE TIBIAL TRAY AND THE TIBIAL INSERT BACK TO DEPUY FOR EVALUATION. THIS HAS BEEN APPROVED BY THE HOSPITAL AND WAS NOTED IN THE PATIENTS CHART THAT THE IMPLANTS WERE BEING RETURNED FOR EVALUATION. DOI: (B)(6) 2017; DOR: (B)(6) 2018; UNKNOWN AFFECTED SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378513 SMARTSET GMV 40G US EO BONE CEMENT : BONE CEMENT MBB DEPUY CMW - 9610921 5450-50-501 8382384 10603295174295

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention ATTUNE CR FB INSRT SZ 7 6MM| ATTUNE CR FEM RT SZ 7 CEM| ATTUNE FB TIB BASE SZ 5 CEM| ATTUNE MEDIAL DOME PAT 38MM| SMARTSET GMV 40G US EO