The literature article entitled, "mechanical failure of revision knee prosthesis at both femoral and tibial modular metaphyseal stem junctions" written by ian g woodgate, john rooney, johnathan s.Mulford, and r.Mark gillies published by journal of orthopaedic case reports 2016 jan-mar: 6 (1): page 40-43 was reviewed.The article's purpose is to discuss a case of a (b)(6) male who received a cemented srom prosthesis after his original tka required revision due to infection.Original implants are unknown.Components implanted during the revision were a cemented srom modular tibial plate, tibial sleeve, uncemented stem extension, femoral cemented noiles rotating hinge component with femoral sleeve and uncemented femoral extention.Cement manufacturer is unknown and patella resurfacing was not performed.Approximately 3 years later, patient experienced a fall and presented with pain, edema and requirement of walking aide due to decreased functional ability.Radiographs reveal broken tibial wire, osteolysis and pedestal formation around both the femoral and distal tibial stem extensions.The "prosthesis was bent at the proximal tibial sleeve and stem junction." the patient was referred for weight loss in order to perform revision knee procedure.After patient lost 120 kgs, the 2nd revision surgery was performed and intraoperative findings included marked metallosis, loosening of the femoral and tibial components at cement-bone interface, fractures on femoral tibial components at the modular metaphyseal sleeve-stem junction.Procedure included debridement, reconstruction with anatomic specific structural and morcellised impaction allograft and then replacement with another srom modular revision stemmed implant cemented into place.Depuy products utilized: srom hinged prosthesis.Adverse events: fall, pain, edema, revision surgery, metallosis requiring debridement, femoral component loosening at cement-bone interface, tibial component loosening at cement-bone interface, tibial prosthesis fracture at sleeve-stem taper junction, femoral prosthesis fracture at sleeve-stem taper junction.
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: product complaint # (b)(4).Investigation summary: no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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