BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PS LIPPED TIBIA INSERT MED 22

    MDR report key: 3012585 · Received March 20, 2013

    Report

    Report Number
    0002249697-2013-01043
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K012172
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING BRACKET CRACK/FRACTURE WAS REPORTED FOR A PS LIPPED TIBIA INSERT MED 22 . THE EVENT WAS CONFIRMED. THE METALLIC SUPPORT ON THE DISTAL SIDE OF THE INSERT WAS FRACTURED. A PORTION OF THE METALLIC SUPPORT WAS RETAINED IN THE INSERT. DAMAGE TO THE POSTERIOR LOCKING MECHANISMS OF THE INSERT WAS ALSO NOTED. MEDICAL RECORDS RECEIVED AND EVALUATION: A MEDICAL REVIEW WAS PERFORMED. NO OPERATIVE NOTES AND NO DOCUMENTED FOLLOW-UP OTHER THAN THE (B)(6) 2013 WERE AVAILABLE. FROM THE MEDICAL INFORMATION PROVIDED THE CLINICIAN DESCRIBED "UNDATED X-RAY COPIES INCLUDE AN AP AND LATERAL OF THE LEFT KNEE, OF POOR QUALITY, DEMONSTRATING A CEMENTED LEFT TOTAL KNEE ARTHROPLASTY WITH STAPLES IN THE MEDIAL FEMORAL CONDYLE AND MEDIAL TIBIAL PLATEAU WITH A METALLIC SPIKE NOTED ON THE LATERAL X-RAY IN THE AREA OF THE PATELLA." THE MEDICAL REVIEW COULD NOT DETERMINE A ROOT CAUSE. DEVICE HISTORY REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW INDICATED THERE HAVE BEEN NO OTHER EVENTS FOR THIS LOT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION, INCLUDING OPERATIVE REPORTS, PROGRESS NOTES AND ADDITIONAL X-RAYS ARE NEEDED TO FULLY INVESTIGATE THE EVENT.

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN DURACON PS INSERT. WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD DURACON KNEE IMPLANTED IN 2001. IN 2007 SCREW BACKED OUT OF TIBIA AND SURGERY WAS PERFORMED TO RE-IMPLANT NEW INSERT AND SCREW. IN 2011 WENT TO ANOTHER SURGEON AND HOSPITAL FOR YET ANOTHER INSERT AND SCREW EXCHANGE. SHOWED UP AT SURGEON'S OFFICE WITH INSERT DISLODGED AND SITTING ANTERIOR TO THE IMPLANT WITH PART OF METAL FROM BENEATH THE INSERT HAVING BROKEN AWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD DURACON KNEE IMPLANTED IN 2001. IN 2007 SCREW BACKED OUT OF TIBIA AND SURGERY WAS PERFORMED TO RE-IMPLANT NEW INSERT AND SCREW. IN 2011 WENT TO ANOTHER SURGEON AND HOSPITAL FOR YET ANOTHER INSERT AND SCREW EXCHANGE. SHOWED UP AT SURGEON'S OFFICE WITH INSERT DISLODGED AND SITTING ANTERIOR TO THE IMPLANT WITH PART OF METAL FROM BENEATH THE INSERT HAVING BROKEN AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115241 PS LIPPED TIBIA INSERT MED 22 IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH 269692

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention