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It was reported that, after a metal-on-metal right total hip arthroplasty had been performed on an unknown date, the patient experienced cobalt level at 270 (h) and chromium levels at 31.0 (h), furthermore, increased subsidence of the femoral stem was found when compared with the previous one which raised suspicion for component loosening.A computerized tomography (ct) was recommended to rule out an acute periprosthetic fracture.However, radiographic findings were the following: stable appearance and alignment of left total hip arthroplasty, degenerative changes in the lower lumbar spine and at the sacroiliac joints, and sclerosis about symphysis pubis likely reflect long-standing stress-related changes.This adverse event was treated by a revision surgery on an unknown date.
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Dear ladies & gentleman, please find the corrected complaint numbers from our previous report within the following text: smith and nephew has received a notification from an external counsel indicating that the information handled through this complaint ((b)(4) / fda report number: (b)(4)) belongs to the same subject and clinical event that was captured under complaint (b)(4) (fda report numbers: (b)(4)).As (b)(4) was received first, smith and nephew is keeping this record and migrating all existing communications & information from (b)(4) to it before closing the later as a duplicated non-valid record.The associated investigation will be continued and the results will be submitted as part of the supplemental reports for (b)(4).
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Dear ladies & gentleman, smith and nephew has received a notification from an external counsel indicating that the information handled through this complaint ((b)(4) / fda report number: 1020279-2022-04177) belongs to the same subject and clinical event that was captured under complaint (b)(4) (fda report numbers: 3005975929-2021-00434 and 3005975929-2021-00435).As (b)(4) was received first, smith and nephew is keeping this record and migrating all existing communications & information from (b)(4) to it before closing the later as a duplicated non-valid record.The associated investigation will be continued and the results will be submitted as part of the supplemental reports for (b)(4).
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H3, h6: it was reported that a right hip revision surgery was performed due to elevated cobalt and chromium levels, increased subsidence of the femoral stem and degenerative changes.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.A review of the historical complaints data for the devices concerned was performed using batch numbers, part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.Without a definitive batch number, a complete review of the historical complaints data could not be performed for the acetabular cup and modular head.No other similar complaints have been identified for the acetabular cup, this will continue to be monitored.Similar complaints have been identified for the modular head and sleeve, however, no action is to be taken as the devices are no longer sold.As no device correct batch numbers were provided for the investigation of the acetabular cup and modular head, their manufacturing record review could not be performed.If more information is received, this investigation will be reopened.In the absence of the actual modular sleeve, the production records were reviewed for the devices reportedly involved in this incident.All released devices involved met manufacturing specifications upon release for distribution.The review of the ifus found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.No further actions are required at this time.A review of historic escalation actions related to the products and similar complaint events was performed.Following the review, no prior applicable escalation actions were identified for the acetabular cup, prior applicable escalation actions were identified for the modular head and sleeve, and confirmed to reduce associated risks as far as possible.No further escalation actions are required.As of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the reported events.The patient impact beyond the reported events cannot be determined with the limited information provided.Based on the available information we can confirm the reported complaint, however without further information our investigation remains inconclusive, and a definitive root cause cannot be determined.Specific factors known to contribute to the alleged fault are excessive physical activity levels, unreasonable stress on replacement system, excessive patient weight, trauma to the joint replacement, loosening of components may increase production of wear particles and accelerate damage to the bone.Should the devices or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.
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