BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRHK TIB INS 20MM MD/LG M2/L2

    MDR report key: 9247358 · Received October 28, 2019

    Report

    Report Number
    0002249697-2019-03633
    Event Type
    Injury
    Date Received
    October 28, 2019
    Date of Event
    October 2, 2019
    Report Date
    January 20, 2020
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRO
    PMA / PMN Number
    K994207
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: UPDATE TO CATALOG AND LOT NUMBERS, UPDATE TO IMPLANT DATE. AN EVENT REGARDING INFECTION INVOLVING AN MRH INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -PRODUCT EVALUATION AND RESULTS: NOT PERFORMED AS PRODUCT WAS NOT RETURNED -MEDICAL RECORDS RECEIVED AND EVALUATION: "CANNOT CONFIRM EVENT, NEED ADDITIONAL INFORMATION; PRIMARY AND REVISION OPERATIVE REPORTS, CLINICAL AND PAST MEDICAL HISTORY, ADDITIONAL SERIAL DATED X-RAYS AND EXAMINATION OF EXPLANTED COMPONENTS." -PRODUCT 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 REPORTED LOT. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE REPORTED STERILE LOT. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION, INCLUDING OPERATIVE REPORTS, PATHOLOGY REPORT, PROGRESS NOTES, X-RAYS AND RETURN OF THE DEVICE ARE NEEDED TO FULLY INVESTIGATE THE EVENT. IF FURTHER INFORMATION BECOMES AVAILABLE OR THE PRODUCT IS RETURNED, THIS INVESTIGATION WILL BE RE-OPENED. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: STERILE FLUTED HEADLESS 1/8" PIN 3.5" LONG; CAT# 7650-2038A; LOT# SC23163H6 TRIATHLON ASYMMETRIC X3 PATELLA; CAT# 5551-G-401; LOT# ERT7 STERILE FLUTED HEADLESS 1/8" PIN 3.5" LONG ; CAT# 7650-2038A; LOT# SC25430HH MRH TIB ROT COMP XS-XL; CAT# 64812100; LOT# 144649 MRH KNEE FEM XL RHT; CAT# 64811141; LOT# A3E6N MRHK TIBIAL SLEEVE; CAT# 64812140; LOT# LHN774 TI DUR REG FLUTED STEM21X155MM; CAT# 64786740; LOT# T3743 MRH TIBIAL B/PLT KEEL LRG 2; CAT# 64813113; LOT# DNJ6T MRHK FEMORAL BUSHING; CAT# 64812110; LOT# LHR617 TI DUR REG FLUTED STEM 17X80MM; CAT# 64786635; LOT# 0051995 MRHK FEMORAL BUSHING; CAT# 64812110; LOT# LHR888 MRHK BUMPER INSERT - NEUTRAL; CAT# 64812130; LOT# LHQ526 MRH AXLE; CAT# 64812120; LOT# CTD32320 IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE..

    Description of Event or Problem · 0

    PATIENT HAD A REVISION MRH PROCEDURE DONE IN MARCH OF THIS YEAR AND IT BECAME INFECTED, PATIENT HAD A HISTORY OF PRIOR INFECTIONS.

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    PATIENT HAD A REVISION MRH PROCEDURE DONE IN MARCH OF THIS YEAR AND IT BECAME INFECTED, PATIENT HAD A HISTORY OF PRIOR INFECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1041030 MRHK TIB INS 20MM MD/LG M2/L2 PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER KRO STRYKER ORTHOPAEDICS-MAHWAH LDT184

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R