BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRHK TIB INS 13MM XS/S S1/S2

    MDR report key: 6620621 · Received June 7, 2017

    Report

    Report Number
    0002249697-2017-01803
    Event Type
    Injury
    Date Received
    June 7, 2017
    Date of Event
    March 1, 2014
    Report Date
    July 21, 2017
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT AFTER THE INITIAL MEDWATCH WAS SUBMITTED: MRH TIB ROT COMP XS-XL; CAT# 6481-2-100; LOT# 052459; GMRS PROXIMAL TIBIAL STANDARD; CAT# 6495-3-102; LOT# 023197DD; GMRS EXTENSION PIECE 30MM; CAT# 6495-6-030 LOT# EFDLP; MRHK TIBIAL SLEEVE; CAT# 6481-2-140; LOT# LDN348; 17MM PRESS FIT FLUTED STEM; CAT# 6495-5-017; LOT# T119364A; TRI PRESS-FIT STEM 18X150MM; CAT# 5566-S-018; LOT# M5K081; MRHK BUMPER INSERT - NEUTRAL; CAT# 6481-2-130; LOT# LCN727; MRHK FEMORAL BUSHING; CAT# 64812110; LOT# LDM999. 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 AN MRH INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS ITEMS WERE NOT RETURNED. -MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE PROVIDED PATIENT INFORMATION AND HISTORY INDICATED: IN THIS CASE NO CORRELATION BETWEEN ANY SPECIFIC DEVICE PROPERTY AND INFECTION CAN BE ESTABLISHED. PATIENT HAD MAINLY BAD LUCK TO BELONG TO THE SMALL PERCENT CATEGORY OF INFECTIOUS ARTHROPLASTY COMPLICATIONS WITH FORTUNATELY A FAVORABLE OUTCOME. AS SUCH, THIS CASE IS CAUSED BY AN ADVERSE MIX OF PATIENT-RELATED AND PROCEDURE RELATED FACTORS. THERE ARE NO DEVICE RELATED FACTORS EVIDENT IN THIS CASE AND IT IS NOT DEVICE RELATED. PROCEDURE-RELATED FACTORS:- INFECTION IS PRIMARILY A PROCEDURE RELATED COMPLICATION, GENERIC TO EVERY ARTHROPLASTY WITH SOMETIMES ADDITIONAL SPECIFIC PATIENT-RELATED RISK FACTORS. MUCH INCREASED INFECTION RISK AFTER COMPLEX KNEE REVISION SURGERY PATIENT-RELATED FACTORS - OBESITY AS SECONDARY FACTOR DEVICE-RELATED FACTORS: - NONE. DIAGNOSIS: - INFECTION IS PRIMARILY A PROCEDURE RELATED COMPLICATION GENERIC TO EVERY ARTHROPLASTY WITH SOMETIMES ADDITIONAL PATIENT-RELATED RISK FACTORS ABOUT WHICH THERE IS NO EXPLICIT INFORMATION IN THIS CASE. -DEVICE HISTORY REVIEW: THE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT OR STERILE LOT REFERENCED. CONCLUSIONS: THE MEDICAL REVIEW INDICATES THAT INFECTION IS PRIMARILY A PROCEDURE RELATED COMPLICATION GENERIC TO EVERY ARTHROPLASTY WITH SOMETIMES ADDITIONAL PATIENT-RELATED RISK FACTORS ABOUT WHICH THERE IS NO EXPLICIT INFORMATION IN THIS CASE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF ADDITIONAL INFORMATION (PATHOLOGY REPORTS/LAB REPORTS) BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. 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 NEEDED A KNEE REVISION DUE TO INFECTION.

    Description of Event or Problem · 1

    PATIENT NEEDED A KNEE REVISION DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398352 MRHK TIB INS 13MM XS/S S1/S2 PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER KRO STRYKER ORTHOPAEDICS-MAHWAH LCN534

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R