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This report is for an unknown.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Concomitant medical products: unknown.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
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This report is being filed after the review of the following journal article: patrick weninger, et al, 2008 ¿anterior cruciate ligament reconstruction using autografts and double biodegradable femoral cross-pin fixation: functional, radiographic and mri outcome after 2-year minimum follow-up¿, knee surg sports traumatol arthrosc 16: pages 988-995 (austria).The purpose of the study was to evaluate the results of autograft acl reconstruction using double biodegradable femoral cross-pin fixation and absorbable tibial interference screw fixation at a minimum follow-up of 24 months.The authors examined 45 patients after acl reconstruction using double biodegradable femoral cross-pin fixation and biodegradable tibial interference screw fixation with a minimum follow-up of 24 months.Clinical evaluation included international knee documentation committee (ikdc) and modified lysholm ¿score.Radiographic analysis included standard x-rays in anterior-posterior and lateral views and telos stress device measurements.Mri was analyzed to obtain information about hardware, intra-articular graft, osseous graft-integration and cartilage.The article describes the following procedure: thirty-eight (84.4%) patients underwent acl reconstruction with hamstring tendons, 6 (13.3%) patients with bptb grafts and 1 (2.2%) patient with a quadriceps tendon autograft.All grafts were fixed with double biodegradable femoral cross-pin fixation (rigid fix®; mitek, johnson & johnson, (b)(4), usa) and tibial absorbable interference screws (megafix®, karl storz (b)(4)).Additionally, staples (8-mm bone staple.Smith & nephew, (b)(4)) or a single-lag screw (6.0 mm cancellous bone screw with short thread and spike washer, synthes, (b)(4)) were inserted tribally to increase tibial pull-out strength.The devices involved were: double biodegradable femoral cross-pin fixation (rigid fix®; mitek, johnson & johnson, (b)(4), usa).Single-lag screw (6.0 mm cancellous bone screw with short thread and spike washer, synthes, (b)(4)).The overall ikdc score revealed 28 (62.2%) patients with normal knee function (group a), 15 (33.3%) patients with nearly normal knee function (group b) and 2 (4.4%) patients with abnormal knee function (group c).No patient had severely abnormal knee function at follow-up (group d).The lysholm score was 94.6 (±7.2) in the operated knee and 98.8 (±7.4) in the non-operated knee.Mean telos stress device values were -1-4.6 (±2.6) in the operated and +3.9 (±2.4) in the non-operated knee.Complications mentioned in the study: among patients who underwent acl reconstruction with hamstring tendons, three (7.9%) patients reported donor-site morbidity.The correct femoral tunnel position was achieved in 43 (95.6%) patients.In one patient, the femoral tunnel was drilled too far anteriorly on the sagittal mri (zone 3) and in one patient, the femoral tunnel was drilled too far laterally in a right knee joint on the coronal mri plane.One patient, who reported transplant re-rupture after a recurrent trauma 3 months prior to follow-up.An enlargement of the femoral tunnel was observed in only two patients.Tribally, a circular bone integration of the graft was documented in 39 (86.7%) patients.A tibial tunnel enlargement was found in three.A perifocal edema and a perifocal cyst were found in two (4.4%) patients.Regarding the biodegradable rigidfix® pins, partial resorption was observed in 31 (68.9%) patients.In all the other patients, the pins were fully visible.Four (8.9%) patients presented with fractured pins, all as three part fractures as demonstrated in fig.2.In two (4.4%) patients, corresponding subchondral bone bruise areas were observed as kissing lesions in the lateral femoral and the posterolateral tibial condyle.Follow-up was 2.6 years in one and 3.2 years in the other patient.Both patients reported giving way-attacks and one had reported a mri-verified disrupted acl graft.The other patient showed an elongated graft on the follow-up mri.Thirty-one (68.9%) patients showed signs of cartilage degeneration on mri at follow-up.It is noteworthy that only two of those patients had shown chondral damage on the initial mri.In the majority of the patients, cartilage changes with signal alteration and cartilage thinning according to outerbridge i° and ii° were found (n = 25; 55.6%).In four (8.9%) patients, cartilage changes according to outerbridge iii° could be observed and two (4.4%) patients showed full thickness cartilage defects representing outerbridge iv° lesions.
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