BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMRS TIBIAL INSERT SMALL 10MM

    MDR report key: 7548410 · Received May 29, 2018

    Report

    Report Number
    0002249697-2018-01595
    Event Type
    Injury
    Date Received
    May 29, 2018
    Date of Event
    May 2, 2018
    Report Date
    July 2, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRO
    UDI-DI
    07613327048810
    PMA / PMN Number
    K023087
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: PMA/510(K)#; MANUFACTURING DATE. CORRECTED DATA: EXPIRATION DATE. AN EVENT REGARDING INFECTION INVOLVING A GMRS INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS NO PRODUCT WAS RETURNED FOR EVALUATION. -MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS NO MEDICAL RECORDS WERE PROVIDED FOR REVIEW. -DEVICE HISTORY REVIEW: ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT OR STERILE LOT REFERENCED. CONCLUSION: THE EVENT ITSELF COULD NOT BE CONFIRMED NOR COULD THE EXACT CAUSE OF THE EVENT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS PRODUCT RETURN, PRE AND POST OPERATIVE X-RAYS, OPERATIVE REPORTS, PATHOLOGY REPORTS INCLUDING THE STRAIN OF INFECTION IDENTIFIED AS WELL AS PATIENT HISTORY AND FOLLOW UP NOTES ARE REQUIRED TO COMPLETE THE INVESTIGATION FOR DETERMINING A ROOT CAUSE. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT'S LEFT KNEE WAS REVISED DUE TO INFECTION (UNKNOWN IF CLINICALLY CONFIRMED OR IDENTIFIED).

    Additional Manufacturer Narrative · 1

    THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: GMRS PROXIMAL TIB SML; CAT# 64953101; LOT# 034732C, GMRS SMALL AXLE; CAT# 64952115; LOT# CTD20592, GMRS SMALL FEMORAL BUSHING; CAT# 64952105; LOT# LHB045, GMRS SMALL FEMORAL BUSHING; CAT# 64952105; LOT# LEX203, GMRS TIB ROTATING SML COMP; CAT# 64953601; LOT# 110398, GMRS DIST FEM COMP SML L 65 MM; CAT# 64952010; LOT# EC3XF, MRHK BUMPER INSERT - NEUTRAL; CAT# 64812130; LOT# LHA158, GMRS TIBIAL INSERT SMALL 10 MM; CAT# 64953010; LOT# LFH112. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. REVIEW OF THE DEVICE HISTORY RECORDS INDICATE THE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE STERILE LOT REFERENCED. NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT'S LEFT KNEE WAS REVISED DUE TO INFECTION (UNKNOWN IF CLINICALLY CONFIRMED OR IDENTIFIED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391652 GMRS TIBIAL INSERT SMALL 10MM PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER KRO STRYKER ORTHOPAEDICS-MAHWAH LFH112 07613327048810

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R