BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRHK TIB INS 16MM MD/LG M2/L2

    MDR report key: 5985746 · Received September 28, 2016

    Report

    Report Number
    0002249697-2016-03082
    Event Type
    Injury
    Date Received
    September 28, 2016
    Date of Event
    April 1, 2016
    Report Date
    August 31, 2016
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRO
    PMA / PMN Number
    K994207
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: MRHK TIB INS 10MM M/L M2/L2; CAT# 6481-3-310; LOT# LCQ417; MRH TIBIAL B/PLT KEEL MED 2; CAT# 6481-3-112; LOT# EBHXJ; TRIATHLON SYMMETRIC X3 PATELLA; CAT# 5550-G-339; LOT# 770W; MRH TIB ROT COMP XS-XL; CAT# 6481-2-100; LOT# 041985; MRHK BUMPER INSERT 3 DEGREES; CAT# 6481-2-133; LOT# LCW220; MRHK TIBIAL SLEEVE; CAT# 6481-2-140; LOT# LDE306. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PAIN INVOLVING AN MRH INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS THE DEVICE WAS NOT RETURNED. MEDICAL RECORDS RECEIVED AND EVALUATION: NO INFORMATION WAS RECEIVED FOR REVIEW WITH THE CLINICAL CONSULTANT. DEVICE HISTORY REVIEW: ALL DEVICES IN THE REPORTED LOT 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. CONCLUSIONS: THE EXACT CAUSE OF THE REPORTED PAIN COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS, OPERATIVE REPORTS, X-RAYS, PATIENT HISTORY & FOLLOW-UP NOTES ARE NEEDED TO INVESTIGATE THIS EVENT FURTHER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    PATIENT CAME BACK TO THE OFFICE IN 2016 COMPLAINING OF SEVERE ONSET OF PAIN AND WAS TAKEN TO THE OPERATING ROOM FOR WASH-OUT AND LINER EXCHANGE.

    Description of Event or Problem · 1

    PATIENT CAME BACK TO THE OFFICE IN 2016 COMPLAINING OF SEVERE ONSET OF PAIN AND WAS TAKEN TO THE OR FOR WASH-OUT AND LINER EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634805 MRHK TIB INS 16MM MD/LG M2/L2 PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER KRO STRYKER ORTHOPAEDICS-MAHWAH LCQ171

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention