BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PKA FEMORAL COMPONENT

    MDR report key: 7324502 · Received March 8, 2018

    Report

    Report Number
    0002249697-2018-00673
    Event Type
    Injury
    Date Received
    March 8, 2018
    Date of Event
    February 9, 2018
    Report Date
    May 15, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING PAIN INVOLVING A FEMORAL COMPONENT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: VISUAL INSPECTION NOTED THAT THE DEVICE WAS RETURNED WITH REMAINING CEMENT AND BIOLOGICAL MATERIAL AROUND THE FIXATION PEGS. EXPLANTATION DAMAGE WAS ALSO NOTICED ON THE DEVICE. CLINICIAN REVIEW: NOT PERFORMED AS MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW. REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT PROPERLY IDENTIFIED. REVIEW OF THE COMPLAINT HISTORY RECORDS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT PROPERLY IDENTIFIED. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 0

    PATIENT HAD A PKA. PATIENT CONTINUED TO HAVE KNEE PAIN AND SWELLING POST SURGERY. SURGEON REVISED THE PKA TO A TKA.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: MCK TIBIAL BASEPLATE-RM/LL-SZ 7; CAT# 180617; LOT# 26450315, MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 7 - 8 MM; CAT# 180737-1; LOT# 2409KE. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    PATIENT HAD A PKA. PATIENT CONTINUED TO HAVE KNEE PAIN AND SWELLING POST SURGERY. SURGEON REVISED THE PKA TO A TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167190 UNKNOWN PKA FEMORAL COMPONENT HIP IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R