BEUDAMED
    FDA Adverse Event Injury Summary report: N

    A200 KNEE SYSTEM

    MDR report key: 5958078 · Received September 16, 2016

    Report

    Report Number
    3007932279-2016-00002
    Event Type
    Injury
    Date Received
    September 16, 2016
    Date of Event
    July 14, 2014
    Report Date
    September 7, 2016
    Manufacturer
    RENOVIS SURGICAL TECHNOLOGIES, INC.
    Product Code
    JWH
    PMA / PMN Number
    K120038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION REPORT ON (B)(4) 2016, (B)(4) FROM THE FDA INFORMED (B)(4) RENOVIS VP OF QUALITY ASSURANCE, IN WRITING, OF MED WATCH REPORT MW5063585 WHICH WAS RECEIVED BY THE FDA POST MARKET SURVEILLANCE DIVISION. ACCORDING TO THE REPORT, PATIENT HAD A BI-LATERAL KNEE REPLACEMENT ON (B)(6) 2014. PER THE REPORT, PATIENT STATED "I HAD BI-LATERAL KNEE REPLACEMENT AND WAS NEITHER WARNED OR INFORMED THAT THERE IS A POSSIBLE REACTION TO THE METAL, AND NOW I'M HAVING A REACTION AND WILL BE HAVING REVISION SURGERY." A PRODUCT COMPLAINT INVESTIGATION WAS IMMEDIATELY INITIATED. THE DEVICE HISTORY RECORDS FOR EACH OF THE DEVICES WERE REVIEWED. ALL DEVICES MEET ALL SPECIFICATIONS, INCLUDING MATERIAL SPECIFICATIONS. DEVICES IMPLANTED RIGHT KNEE: 1201-212-400 FEMORAL COMPONENT CR SIZE 4 RIGHT LOT NO. 286-11. 1201-222-400 TIBIAL BASEPLATE CR, STEMMED, SIZE 4 RIGHT, LINER B LOT NO. 1542-35. 1201-232-310 TIBIAL INSERT, ULTRACONGRUENT, CR, SIZE B 10MM, RIGHT, E-MAX LOT NO. 1532-27. 1201-341-230 PATELLA COMPONENT, SIZE 2, 30MM LOT NO. 1562-51. RENOVIS IFU 4201-001 LISTS POSSIBLE ADVERSE EFFECTS ASSOCIATED WITH TOTAL KNEE ARTHROPLASTY, INCLUDING METAL SENSITIVITY AND HISTOLOGICAL REACTIONS. EARLY AND LATE ALLERGIC REACTIONS ARE ALSO DESCRIBED. INFORMATION WAS RECEIVED FROM A CONSUMER ALONE. SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED. IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS, SUCH AS BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), ETC., ARE UNKNOWN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. DEVICES NOT EXPLANTED AT TIME OF REPORT.

    Description of Event or Problem · 1

    ON 08/10/2016, MED WATCH REPORT MW5063585 WAS RECEIVED BY RENOVIS FROM THE FDA POSTMARKET SURVEILLANCE DIVISION. PRIOR TO THIS DATE, RENOVIS WAS UNAWARE OF THIS EVENT. IN THE REPORT PATIENT (SS) STATES "I HAD BI-LATERAL KNEE REPLACEMENT AND WAS NEITHER WARNED OR INFORMED THAT THERE IS A POSSIBLE REACTION TO THE METAL AND NOW I'M HAVING A REACTION AND WILL BE HAVING REVISION SURGERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607958 A200 KNEE SYSTEM TOTAL KNEE PROTHESIS SYSTEM JWH RENOVIS SURGICAL TECHNOLOGIES, INC. 286-11

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention