Patient underwent primary lm unicompartmental knee surgery on (b)(6) 2020 when a sigma partial knee was utilized (dr (b)(6), (b)(6)).Patient presented with a painful knee and the tibial component was revised on (b)(6) 2021 (dr (b)(6), (b)(6) hospital) (see (b)(4)).Patient initially did well and presented again with a painful knee - this resulted on a poly exchange of the tibial component and a washout on (b)(6) 2021 (dr (b)(6), (b)(6)) (see (b)(4)).Patient was then doing well until approximately 6 months ago when he started to experience a painful knee.A decision was made to revise the sigma partial to a total knee with a stem and sleeved tibia.On opening the knee ((b)(6) 2022, dr (b)(6), (b)(6) hospital) the tibial component was found to be loose - with the failure at the bone cement/ bone interface.All components were removed and stemmed and sleeved attune revision tibial component implanted along with a primary ps femoral component.Did the patient experience a post-op device malfunction? unknown, if yes, please describe.Loose tibial component - revision to total knee , did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? yes, did the patient require revision surgery or hardware removal? yes, facility name of original implant : (b)(6), was device explanted? true, hardware/explant removal due to: pain and loosening, did patient require revision surgery? true, if yes, date of revision surgery.(b)(6) 2022, reason for revision surgery.Pain, patient status/ outcome / consequences , patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? pain, infection, pain, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, other information bmi of 40, is the patient part of a clinical study unknown, (b)(4) device property of none, device in possession of none, (b)(4) device property of none, device in possession of none, (b)(4) device property of none, device in possession of none.By checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.True.
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Product complaint # (b)(4).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.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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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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