BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRH XS/S/M LONG XOVER

    MDR report key: 8575223 · Received May 2, 2019

    Report

    Report Number
    0002249697-2019-01844
    Event Type
    Injury
    Date Received
    May 2, 2019
    Date of Event
    April 5, 2019
    Report Date
    September 24, 2019
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRO
    PMA / PMN Number
    K002552
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: GMRS DIST FEM COMP SML L 65MM; CAT# 64952010; LOT#AP46K. GMRS EXTENSION PIECE 40MM; CAT#64956040 AY43F. MRS 11MM X 127MM FEMORAL STEM; CAT#64853011; LOT#146386B. GMRS SMALL FEMORAL BUSHING; CAT#64952105; LOT#LFB654. GMRS SMALL FEMORAL BUSHING; CAT#64952105; LOT#LFB655. GMRS SMALL AXLE; CAT#64952115; LOT#CTD2046. MRHK TIBIAL SLEEVE; CAT#64812140; LOT#LEX909. MRHK BUMPER INSERT ¿ NEUTRAL; CAT#64812130; LOT#LFC243. MRH TIB ROT COMP XS-XL; CAT#64812100; LOT#88768. SIMPLEX ABC CE MARK 1 PCK; CAT#61969001; LOT#BFX026. SIMPLEX ABC CE MARK 1 PCK; CAT#61969001; LOT#BDX016. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. AN EVENT REGARDING INFECTION INVOLVING A MRH TIBIAL COMPONENT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -PRODUCT EVALUATION AND RESULTS: NOT PERFORMED AS NO PRODUCT WAS RETURNED FOR EVALUATION. -CLINICIAN REVIEW: NOT PERFORMED AS NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. -PRODUCT HISTORY REVIEW: INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES.. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT OR STERILE LOT REFERENCED. CONCLUSIONS: THE EVENT ITSELF COULD NOT BE CONFIRMED AND EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS DEVICE 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: UPDATE TO EVENT DESCRIPTION, IMPLANT, AND EXPLANT DATES. AN EVENT REGARDING INFECTION AND LOOSENING INVOLVING AN UNKNOWN FEMORAL COMPONENT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: NOT PERFORMED AS NO PRODUCT WAS RETURNED FOR EVALUATION. CLINICIAN REVIEW: NOT PERFORMED AS NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. PRODUCT HISTORY REVIEW: NOT PERFORMED AS NO LOT INFORMATION WAS PROVIDED. COMPLAINT HISTORY REVIEW: NOT PERFORMED AS NO LOT INFORMATION WAS PROVIDED. CONCLUSIONS: THE EVENT ITSELF COULD NOT BE CONFIRMED AND EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS DEVICE IDENTIFICATION AND 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

    UPDATE: REVISION SURGERY TOOK PLACE ON (B)(6) 2019 DUE TO INFECTION AND LOOSENING BECAUSE OF PATIENT DISEASE, NOT BECAUSE OF IMPLANT FAILURE. NO FURTHER INFORMATION AVAILABLE DUE TO HOSPITAL CONFIDENTIALITY. SALES REP IN MALAYSIA REPORTED BOOKING FOR REVISION SURGERY FOR GMRS DISTAL FEMUR IN MY AREA POSSIBLE ON DATE (B)(6) 2019, IMPLANT LOOSENING DUE TO BONE INFECTION. DETAILED INFORMATION ON THE PRODUCT, PATIENT ETC WILL ONLY BE AVAILABLE AFTER THE REVISION SURGERY ON (B)(6) 2019.

    Description of Event or Problem · 0

    UPDATE: REVISION SURGERY TOOK PLACE ON (B)(6) 2019 DUE TO INFECTION AND LOOSENING BECAUSE OF PATIENT DISEASE, NOT BECAUSE OF IMPLANT FAILURE. NO FURTHER INFORMATION AVAILABLE DUE TO HOSPITAL CONFIDENTIALITY. SALES REP IN MALAYSIA REPORTED BOOKING FOR REVISION SURGERY FOR GMRS DISTAL FEMUR IN MY AREA POSSIBLE ON DATE (B)(6) 2019, IMPLANT LOOSENING DUE TO BONE INFECTION. DETAILED INFORMATION ON THE PRODUCT, PATIENT ETC WILL ONLY BE AVAILABLE AFTER THE REVISION SURGERY ON (B)(6) 2019.

    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.

    Description of Event or Problem · 1

    SALES REP IN MALAYSIA REPORTED BOOKING FOR REVISION SURGERY FOR GMRS DISTAL FEMUR POSSIBLE ON DATE (B)(6) 2019, IMPLANT LOOSENING DUE TO BONE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367145 MRH XS/S/M LONG XOVER PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER KRO STRYKER ORTHOPAEDICS-MAHWAH 068813D

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R