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It was reported that, after right bhr surgery was performed on (b)(6) 2020 due to osteoarthritis, long-standing right hip, and groin pain, the patient experienced pain and progressive limp.An mri identified presence of adverse local tissue reaction and elevation in cobalt and chromium levels.This adverse event was treated with a revision surgery on (b)(6) 2021, in which severe synovitis and dehiscence of the anterolateral capsular was observed.Repair to the trochanter was required.Patient's current health status is unknown.
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H3, h6.It was reported that right hip revision surgery was performed.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 acetabular cup and the femoral head was performed using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product and using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe prior 12 months as of the complaint aware date.No other complaints were identified to involve this batches.Other similar complaints were identified for the part numbers and the reported/related failure modes.This will continue to be monitored.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All released devices involved met manufacturing specifications upon release for distribution review of the product ifu 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.The available medical documents were reviewed.The revision operative note did not note any findings adverse local tissue reaction.Per the surgical technique, the acetabular component is to be impacted with 15-20 degrees of anteversion and 40-45 degrees abduction.However, the surgeon noted intraoperatively that the acetabular component was ¿in basically neutral version¿.It is unknown if this position of the acetabular component was a migration since implantation and if it led to accelerated wear and the reported elevation in cobalt and chromium levels, along with the intraoperative findings of synovitis and dehiscence of the anterolateral abductors trochanter.Although it was reported the patient had elevated cobalt and chromium levels, neither the levels nor the lab reports were provided for review.Without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the reported clinical reactions cannot be confirmed.It cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant or implant failure.The patient impact beyond cannot be determined.Without the return of the devices used in treatment or additional information we cannot advance the investigation or confirm this complaint; 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.H11: corrected information in h6 (health effect - clinical code).
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