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Device Problem
Inadequacy of Device Shape and/or Size (1583)
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Patient Problem
Failure of Implant (1924)
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Event Type
Injury
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Event Description
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This report is being filed after the subsequent review of the following journal article ¿injury to the infrapatellar branch of the saphenous nerve, a possible cause for anterior knee pain after tibial nailing?¿ leliveld, m., verhofstad, m.(2012).A retrospective review was performed between june 1998 and june 2008 on 72 traumatic tibial shaft fractures, both radiographs and case notes were evaluated retrospectively.The mean follow up time was between 37 to 84 months.All fractures were treated with an unreamed tibial nail (utn; synthes, (b)(4)).Five patients required an immediate fasciotomy.There were four cases of malunion and malalignment occurred three times, one patient had a deep infection.One patient developed a neuroma at the nail entry site which has been resected.Eight locking screws were removed of which three to accomplish dynamisation, the remaining five were removed for they caused pain or discomfort to the patient.Nail exchange occurred three times and four nails were exchanged for a different implant.Bone grafting had been used in three cases.At follow-up 33 of the 72 nails had been removed.Fourteen nails were taken out for they caused general discomfort and twelve nails because of knee pain.A deep infection required nail removal in one patient.Another nail was found to be too short postoperatively and was exchanged.The remaining nails were removed to correct malunion or to achieve union using various implants.Of the 39 nails that were in situ, nineteen were found to be prominent on the lateral radiographs.Sensory deficits related to the infrapatellar nerve were detected in 43 patients.Numbness in the dermatome of the infrapatellar nerve lateral or caudolateral to the incision as an isolated symptom was found in 31 patients.Isolated neuropathic pain in the same area was found in seven patients.A combination of both was detected in five cases.Decreased sensation on the medial side of the calf (distribution area of the sartorial branch of the saphenous nerve) was found in one patient.Another patient suffered from hyperesthesia of the superficial peroneal nerve.Finally, one patient complained of numbness in his first web space without additional symptoms.This report is for an unknown unreamed tibial nail.This is report 3 of 3 for (b)(4).
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Manufacturer Narrative
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Device was used for treatment not diagnosis.Leliveld, m., verhofstad, m.(2012) injury to the infrapatellar branch of the saphenous nerve, a possible cause for anterior knee pain after tibial nailing? injury, int.J.Care injured, 43, pp: 779¿783.This report is for an unknown unreamed tibial nail.(b)(6).Investigation could not be completed and no conclusion could be drawn, as no devices were returned and no lot numbers or part numbers were provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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