As reported: patient reported to a stryker employee about an implant in her leg that is giving her trouble.Patient stated she broke her tibia and received an implant in 2008.She stated that she noticed a green color under her kneecap, she said she did not fall.She got x-rays done and her doctor stated that it looks like the screws are coming out." additionally, the patient reported that she has long rod from her knee almost to her ankle with 3 pins.She always had a small bulge near her knee but it got worse and almost got green in that region once, she does bruise easily and is on blood thinners.
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The reported event that an unknown t2 tibia nail alleged of issue ¿implant - dislocated¿ could not be confirmed, since as per the additional information received, the patient is doing fine and the treating doctor has disregarded any event of dislocation either of the nail or the screw.A device inspection was not possible since the affected device was not returned, neither was deemed necessary as per the stated event.The batch record could not be reviewed because the lot number was not communicated.A review of the labeling did not indicate any abnormalities.Some additional information was received from the patient: "[.] she went to a orthopedic doctor who have confirmed that there is nothing wrong with her rod and screws, she refer to the screws as pins, she was told that the pins are in good position, not migrating out locked position.She is doing fine, pain free and would like to close her case [.] no further action is required.She previously mentioned that she bruises easily so maybe that¿s what that was, pain and bruising in the kneecap region.¿ based strictly on the additional information it is clear that there is no apparent harm or failure caused to the patient due the nail or the screw.The implants are intact inside the patient.The patient also has withdrawn the complaint and thus this whole event is considered as a misjudgment on the part of the patient.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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As reported: patient reported to a stryker employee about an implant in her leg that is giving her trouble.Patient stated she broke her tibia and received an implant in 2008.She stated that she noticed a green color under her kneecap, she said she did not fall.She got x-rays done and her doctor stated that it looks like the screws are coming out." additionally, the patient reported that she has long rod from her knee almost to her ankle with 3 pins.She always had a small bulge near her knee but it got worse and almost got green in that region once, she does bruise easily and is on blood thinners.
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