BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MET ENCAP INSERT DURATION SML

    MDR report key: 2981615 · Received February 27, 2013

    Report

    Report Number
    0002249697-2013-00808
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 5, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRO
    PMA / PMN Number
    K002552
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THERE WERE NO REPORTED DISCREPANCIES AND THERE WERE NO OTHER EVENTS FOR THE REFERENCED LOT. THE INSERT BROKE FROM OFF-AXIS LOADING. THE INTERNAL METAL STEM WAS RUBBING ALONG ONE SIDE OF THIS INSERT. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE SURFACES EXAMINED. IT WAS ALSO NOTED THAT THE UPPER PART OF THE INSERT BECAME SEPARATED FROM THE PROXIMAL TIBIAL COMPONENT MOST LIKELY AFTER FRACTURE OF THE DISTAL PORTION OF THE INSERT WHICH REMAINED INSIDE THE PROXIMAL TIBIAL COMPONENT. THE INVESTIGATION CONCLUDED THAT THE FRACTURE OF THE DISTAL PORTION OF THE INSERT WAS CAUSED BY OFF-AXIS LOADING WHEREBY THE INTERNAL METAL STEM WAS RUBBING ALONG ONE SIDE OF THIS INSERT. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE SURFACES EXAMINED. THE MEDICAL REVIEW INDICATED THAT THE SEGMENTAL RESECTION SURGERY AND LOSS OF FIXATION OF THE PATELLAR TENDON WITH THE OVERLOAD EFFECTS FURTHER AGGRAVATED BY EXCESSIVE PATIENT ACTIVITY RESULTED IN AXIAL INSTABILITY WITH REPETITIVE AXIAL SUBLUXATIONS AND FINALLY IN A FULL DISLOCATION OF THE TIBIAL ROTATING HINGE COMPONENT FROM THE PROXIMAL TIBIAL COMPONENT. THERE IS NO EVIDENCE OF DEVICE-RELATED FACTORS IN THIS EVENT. THE REPORTED EVENT REGARDING AN INSERT FRACTURE INVOLVING A METAL ENCAPSULATED INSERT WAS CONFIRMED.

    Description of Event or Problem · 1

    ON (B)(6) AT MORNING X-RAY MEETING, PATIENT WAS PRESENTED WITH DISLOCATED MRS/MRH PROSTHESIS. PATIENT WAS WELL KNOWN BY SURGEONS TO HAVE REQUIRED MULTIPLE REVISIONS TO THIS PROSTHESIS FOR VARIOUS DISLOCATIONS FROM AN ACTIVE LIFESTYLE (AKA SKY DIVING). SURGEONS QUESTIONED HOW DISLOCATION OCCURRED AND PATIENT REPORTED ROLLING OVER IN BED. UPON X-RAYS, ANTERIOR DISLOCATION OF THE TRH COMPONENT WAS CONFIRMED. PLAN WAS TO OPENLY REDUCE THE PROSTHESIS; PERFORMING AND INSPECTION OF ALL COMPONENTS AND CHANGING WHAT WAS REQUIRED. DURING THE SURGERY, IT WAS CONFIRMED THAT THE COMPONENT WAS DISLOCATED. UPON FULL EXPOSURE, IT WAS NOTED THAT THE 21MM TIBIAL INSERT WAS FRACTURED. THE SURGEON REMOVED THE MAJORITY OF THE INSERT BY SLIDING OFF THE TRH COMPONENT AND USED A HOWARTH ELEVATOR TO REMOVE THE SMALL REMAINING FRAGMENT THAT REMAINED AT THE BOTTOM OF THE MRS TIBIA (AREA THAT THE TRH COMPONENT SITS INTO THE MRS TIBIA). A NEW 21MM TIBIAL INSERT WAS INSERTED IN PLACE OF THE REMOVED ITEM AND ALL OTHER REMAINING POLY COMPONENTS AND THE AXLE WERE CHANGED BECAUSE OF SURGEON PREFERENCE.

    Description of Event or Problem · 1

    ON (B)(6) AT MORNING X-RAY MEETING, PATIENT WAS PRESENTED WITH DISLOCATED MRS/MRH PROSTHESIS. PATIENT WAS WELL KNOWN BY SURGEONS TO HAVE REQUIRED MULTIPLE REVISIONS TO THIS PROSTHESIS FOR VARIOUS DISLOCATIONS FROM AN ACTIVE LIFESTYLE (AKA SKY DIVING). SURGEONS QUESTIONED HOW DISLOCATION OCCURRED AND PATIENT REPORTED ROLLING OVER IN BED. UPON X-RAYS, ANTERIOR DISLOCATION OF THE TRH COMPONENT WAS CONFIRMED. PLAN WAS TO OPENLY REDUCE THE PROSTHESIS; PERFORMING AND INSPECTION OF ALL COMPONENTS AND CHANGING WHAT WAS REQUIRED. DURING THE SURGERY, IT WAS CONFIRMED THAT THE COMPONENT WAS DISLOCATED. UPON FULL EXPOSURE, IT WAS NOTED THAT THE 21MM TIBIAL INSERT WAS FRACTURED. THE SURGEON REMOVED THE MAJORITY OF THE INSERT BY SLIDING OFF THE TRH COMPONENT AND USED A HOWARTH ELEVATOR TO REMOVE THE SMALL REMAINING FRAGMENT THAT REMAINED AT THE BOTTOM OF THE MRS TIBIA (AREA THAT THE TRH COMPONENT SITS INTO THE MRS TIBIA). A NEW 21MM TIBIAL INSERT WAS INSERTED IN PLACE OF THE REMOVED ITEM AND ALL OTHER REMAINING POLY COMPONENTS AND THE AXLE WERE CHANGED BECAUSE OF SURGEON PREFERENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83228 MET ENCAP INSERT DURATION SML IMPLANT KRO STRYKER ORTHOPAEDICS-MAHWAH LPTB916

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention