BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRHK TIB INS 13MM XS/S S1/S2

    MDR report key: 13598705 · Received February 25, 2022

    Report

    Report Number
    0002249697-2022-00279
    Event Type
    Injury
    Date Received
    February 25, 2022
    Date of Event
    November 9, 2021
    Report Date
    February 25, 2022
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRO
    UDI-DI
    07613327043792
    PMA / PMN Number
    K994207
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: CAT# 64811111; MRH KNEE FEM S RGT; LOT# JP26E, CAT# 64813110; MRH TIBIAL B/PLT KEEL SML 1; LOT# LNN9H, CAT# 5560-S-215; TRIATHLON CEMENTED STEM-15MM X 100MM; LOT# 0105704D, CAT# 5560-S-115; TRIATHLON CEMENTED STEM-15MM X 50MM; LOT# 0105701H, CAT# 64812110; MRHK FEMORAL BUSHING; LOT# LKM975, CAT# 64812100; MRH TIB ROT COMP XS-XL; LOT# 172881A, CAT# 64812110; MRHK FEMORAL BUSHING; LOT# LKM031, CAT# 64812133; MRHK BUMPER INSERT 3 DEGREES; LOT# LKP580, CAT# 64812120; MRH AXLE; LOT# CTD54902, AND CAT# 64812140; MRHK TIBIAL SLEEVE; LOT# LKM729. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE.

    Additional Manufacturer Narrative · 0

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: CAT# 64811111; MRH KNEE FEM S RGT; LOT# JP26E, CAT# 64813110; MRH TIBIAL B/PLT KEEL SML 1; LOT# LNN9H, CAT# 5560-S-215; TRIATHLON CEMENTED STEM-15MM X 100MM; LOT# 0105704D, CAT# 5560-S-115; TRIATHLON CEMENTED STEM-15MM X 50MM; LOT# 0105701H, CAT# 64812110; MRHK FEMORAL BUSHING; LOT# LKM975, CAT# 64812100; MRH TIB ROT COMP XS-XL; LOT# 172881A, CAT# 64812110; MRHK FEMORAL BUSHING; LOT# LKM031, CAT# 64812133; MRHK BUMPER INSERT 3 DEGREES; LOT# LKP580, CAT# 64812120; MRH AXLE; LOT# CTD54902, AND CAT# 64812140; MRHK TIBIAL SLEEVE; LOT# LKM729. 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 RIGHT TKA OUTSIDE CORS SCOPE IN 2013, REQUIRED AN MUA ONE MONTH LATER. THE PATIENT DEVELOPED PJI WITH MSSA AND LATER WITH MRSA. HAS BEEN REVISED 5 TIMES OUT OF CORS SCOPE. IN (B)(6) 2017 THE PATIENT IS REIMPLANTED, NOW ENTERING CORS REGISTRY. PATIENT DEVELOPS AGAIN PJI AND INSTABILITY. PATIENT UNDERGOES RESECTION AND REVISION ON (B)(6) 2021. REPORTED IN CORS PER 7990KNEE COVERED IN A SEPARATE REPORT. PATIENT AGAIN PRESENTS WITH PJI, SO A RESECTION ARTHROPLASTY IS DONE ON (B)(6) 2021, WITH PLANS OF REIMPLANTATION LATER ON. PJI PERSIST, SO PATIENT IS TREATED FINALLY WITH AN RIGHT KNEE ARTHRODESIS ON (B)(6) 2022.

    Description of Event or Problem · 0

    PATIENT HAD A RIGHT TKA OUTSIDE CORS SCOPE IN 2013, REQUIRED AN MUA ONE MONTH LATER. THE PATIENT DEVELOPED PJI WITH MSSA AND LATER WITH MRSA. HAS BEEN REVISED 5 TIMES OUT OF CORS SCOPE. IN (B)(6) 2017 THE PATIENT IS REIMPLANTED, NOW ENTERING CORS REGISTRY. PATIENT DEVELOPS AGAIN PJI AND INSTABILITY. PATIENT UNDERGOES RESECTION AND REVISION ON (B)(6) 2021. REPORTED IN CORS PER 7990KNEE COVERED IN A SEPARATE REPORT. PATIENT AGAIN PRESENTS WITH PJI, SO A RESECTION ARTHROPLASTY IS DONE ON (B)(6) 2021, WITH PLANS OF REIMPLANTATION LATER ON. PJI PERSIST, SO PATIENT IS TREATED FINALLY WITH AN RIGHT KNEE ARTHRODESIS ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1229458 MRHK TIB INS 13MM XS/S S1/S2 PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER KRO STRYKER ORTHOPAEDICS-MAHWAH 6481-3-213 LKA452 07613327043792

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention| H