BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCK MAXIMUM CONGRUENT KNEE) KNEE SYSTEM - BMT SPLINED KNEE STM 20X120

    MDR report key: 6118554 · Received November 21, 2016

    Report

    Report Number
    0001825034-2016-04776
    Event Type
    Injury
    Date Received
    November 21, 2016
    Report Date
    July 8, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. IMPLANTED ON AN UNKNOWN DATE IN FEBRUARY, 2003. PATIENT CODE - 2033 RASH. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH SINCE THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE MAY BE NECESSARY. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING A REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND, IF WARRANTED, FURTHER MEDWATCH REPORTS WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT PRODUCT(S): - MAXIM CONSTRAINED LEFT FEMUR 65MM, CATALOG 145232, LOT 644400; MAXIM FEMORAL AUGMENT 65X10MM MR/LL, CATALOG 145362, LOT 487540; MAXIM FEMORAL AUGMENT 65X10MM ML/LR, CATALOG 145352, LOT 523380; MAXIM FEMORAL AUGMENT 65X6MM MR/LL, CATALOG 145342, LOT 569080; MAXIM FEMORAL AUGMENT 65X6MM ML/LR, CATALOG 145332, LOT 503960; BIOMET STEMMED TIBIAL TRAY 71MM, CATALOG 141513, LOT 505490; BIOMET TIBIAL BLOCK 10MM, CATALOG 141763, LOT 567480; BIOMET SPLINED KNEE STEM 18X120MM, CATALOG 141658, LOT 843510; BIOMET HIP FRACTURE FEMUR 14X150MM, CATALOG 162903, LOT 185510; 28MM MODULAR FEMORAL HEAD CATALOG 163662, LOT 024960; RINGLOC BIPOLAR ACETABULAR SHELL 28X46MM, CATALOG 11-165216, LOT 941860; AGC ANATOMIC FEMUR RIGHT 65MM, CATALOG 152834, LOT 013190. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1825034-2017-01832, 1825034-2017-01833, 1825034-2017-01834, 1825034-2017-01835, 1825034-2017-01836, 1825034-2017-01837, 1825034-2017-01838, 1825034-2017-01839, 1825034-2017-01840, 1825034-2017-01841, 1825034-2017-01842, 1825034-2017-01843.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE COMPLAINT SAMPLES WERE EVALUATED THROUGH DEVICE HISTORY RECORD REVIEWS AND COMPLAINT HISTORY REVIEWS AND THE REPORTED EVENT COULD NOT BE CONFIRMED. DEVICE HISTORY RECORD REVIEWS WERE PERFORMED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE IDENTIFIED. A REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTIONS ARE REQUIRED. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED ALLERGIC REACTION WAS DETERMINED TO BE RELATED TO THE PATIENT¿S CONFIRMED NICKEL ALLERGY. HOWEVER, A DEFINITIVE ROOT CAUSE OF THE LIGAMENTOUS LOOSENING COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    PATIENT HAS BEEN EXPERIENCING AN ALLERGIC REACTION TO THE KNEE PROSTHESIS WHICH HAS ALSO CAUSED LOOSENING OF THE IMPLANTS, FOR WHICH A REVISION MAY BE SCHEDULED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY APPROXIMATELY 14 YEARS AGO AND HAS EXPERIENCED A RASH AS WELL AS ITCHING FOR YEARS; THE PATIENT HAS ALLEGEDLY TESTED POSITIVE FOR A NICKEL ALLERGY. IT WAS FURTHER REPORTED THAT THE PATIENT¿S LEFT KNEE IS ALSO ¿LOOSE,¿ WHICH HAS CAUSED FALLING. IT WAS INDICATED THAT THE KNEE IS TO BE REVISED, HOWEVER, NO REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769870 MCK MAXIMUM CONGRUENT KNEE) KNEE SYSTEM - BMT SPLINED KNEE STM 20X120 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 080920

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention