BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRHK TIB INS 16MM MD/LG M2/L2

    MDR report key: 3140319 · Received May 31, 2013

    Report

    Report Number
    0002249697-2013-01825
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 8, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRO
    PMA / PMN Number
    K994207
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. NOT RETURNED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DISLOCATION OF THE KNEE INVOLVING AN MRH INSERT COMPONENT WAS REPORTED. THE EVENT WAS CONFIRMED. THE MEDICAL REVIEW CONCLUDED THAT DEVICE-RELATED ISSUES DO NOT APPEAR TO BE PRESENT AS BASED ON THE CURRENT INFORMATION WHILE THE DISCUSSED FAILURE SCENARIO THROUGH A FALLING INCIDENT PROVIDES A VERY PLAUSIBLE EXPLANATION AS ROOT CAUSE FOR THE EVENT RESULTING IN A SIGNIFICANT OVERLOAD CONDITION OF THE KNEE. THIS PI CASE IS NOT DEVICE-RELATED BUT HAS ITS ROOT FAILURE CAUSE IN AN ADVERSE PATIENT-RELATED EVENT. DEVICE HISTORY REVIEW: THE DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: BASED ON THE MEDICAL REVIEW THE ROOT CAUSE OF THIS EVENT IS THE TRAUMA THE PATIENTS KNEE EXPERIENCED DURING THE FALL IN THE EARLY POST OPERATIVE PHASE. THE FALLING INCIDENT PROVIDES A VERY PLAUSIBLE EXPLANATION AS ROOT CAUSE FOR THE EVENT RESULTING IN A SIGNIFICANT OVERLOAD CONDITION OF THE KNEE. THIS PI CASE IS NOT DEVICE-RELATED BUT HAS ITS ROOT FAILURE CAUSE IN AN ADVERSE PATIENT-RELATED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT THE PATIENT WAS USING THE RESTROOM AND SLIPPED WHEN STANDING UP AND HYPER FLEXED HER KNEE WHILE FALLING ON THE KNEE WITH A DISTAL FEMUR. DURING THE SURGERY, SURGEON OPENED THE CAPSULE TO FIND THE POLY REMOVED FROM THE BASEPLATE AND THE ROTATING PIECE OUT OF THE BASEPLATE. SURGEON REMOVED ALL PLASTIC PIECES AND THEN REPLACED WITH A THICKER POLY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT THE PATIENT WAS USING THE RESTROOM AND SLIPPED WHEN STANDING UP AND HYPER FLEXED HER KNEE WHILE FALLING ON THE KNEE WITH A DISTAL FEMUR. DURING THE SURGERY, SURGEON OPENED THE CAPSULE TO FIND THE POLY REMOVED FROM THE BASEPLATE AND THE ROTATING PIECE OUT OF THE BASEPLATE. SURGEON REMOVED ALL PLASTIC PIECES AND THEN REPLACED WITH A THICKER POLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241349 MRHK TIB INS 16MM MD/LG M2/L2 IMPLANT KRO STRYKER ORTHOPAEDICS-MAHWAH LCP579

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention