ZIMMER GMBH CMN FEMORAL NAIL, CCD 125, LEFT, 11.5 MM, 42 CM; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS
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Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problems
Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994)
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Event Type
Injury
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Manufacturer Narrative
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The manufacturer did not receive devices, x-rays, or other source documents for review.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.Should additional information become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).
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Event Description
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It was reported that the patient was implanted a cmn femoral nail, ccd 125, left, 11.5 mm, 42 cm on (b)(6) 2016 on the left side.(as exact date of implantation is unknown the last day of the reported month was taken as implantation date.) it was also reported by patient: "the month of (b)(6) i started getting pain in my left knee.In the month of august out walking i got terrible pain up near my hip.What we discovered was the screws down by my knee had broke in half and the rod had broke in half up by my hip, this let my femur break all over again." the patient underwent a revision surgery on (b)(6) 2016.(the exact date of revision is unknown.It was reported that the revision surgery took place 3 month after implantation, therefore (b)(6) 2016 was taken as revision date.) as the date of the event is unknown the field was left empty.Additional information has been requested and is currently not available.
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Manufacturer Narrative
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Trend analysis: no trend identified.Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Event summary: it was reported, that a patient was implanted with a cnn nail in (b)(6) 2016 and had to be revised due to pain in her knee and hip, screw and implant breakage.Femur re-fractured.Review of received data: a mail from the patient was received on (b)(6) 2016.The mail describes that the patient had an accident and broke her both legs.Znn nailing system was implanted.After 2 weeks she had a post op control.The doctor said the bone seemed to be healing well.In the same month the patient started getting pain in her left knee.Afterwards, she got terrible pain.She visited the doctor.The doctor confirmed that the nail was broken and a screw down in her knee was broken in half.It is unknown what kind of screw this is.A revision surgery was performed.The explants were saved for the patient.Devices analysis: no product was returned to zimmer (b)(4) for in-depth analysis.Review of product documentation: the correct implantation of a znn nailing system is described in the surgical technique.Conclusion summary: it was reported, that a patient was implanted with a znn nail in (b)(6) 2016 and had to be revised due to pain in her knee and hip, screw and nail breakage.The femur bone was also re-fractured.The revision was done in (b)(6) 2016.Neither x-rays, operative notes, office visit notes, nor devices or photos of the explanted implant(s) were received; therefore the condition of the component(s) is unknown.Patient factors that may affect the performance of the components such as bone quality, activity level, type of activity (low impact vs.High impact), and relevant medical history are unknown.Adherence to rehabilitation protocol is unknown.In conclusion, due to significant lack of information, it is impossible to perform a meaningful analysis of the reported event.The need for corrective actions is not indicated and zimmer (b)(4) considers this case as closed.(b)(4).
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