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It was reported that, after a primary bhr resurfacing construct had been implanted on the plaintiff¿s left hip on (b)(6) 2008, the plaintiff experienced a post-operative cellulitis which required readmission to hospital in two occasions, in order to perform two incision and drainage procedures on (b)(6) 2008 and (b)(6) 2008.During both procedures, a synovectomy was performed, where the hip and wound were copiously irrigated.After the second procedure, and adjustment in his iv antibiotic therapy was prescribed.The patient was discharged in stable condition on the 3rd postoperative day.
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H3, h6: it was reported that the patient underwent two consecutive incision and drainage procedures due to a postoperative cellulitis following primary left hip surgery.As of today, the implanted devices, all of which were used in treatment, and additional information has been requested for this complaint but has not become available.A review of the historical complaints data for the acetabular cup was performed.Using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product.Using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe of 12 months prior to the date in which the incident was reported.A similar complaint was identified to involve this batch; however, it relates to the same patient.No other similar complaints have been identified for the part number and the reported failure mode in this timeframe.A review of the historical complaints data for the femoral head was performed.Using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product.Using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe of 12 months prior to the date in which the incident was reported.A similar complaint was identified to involve this batch; however, it relates to the same patient.No other similar complaints have been identified for the part number and the reported failure mode in this timeframe.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 and manufacturing sterility requirements 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.The available medical documents were reviewed.The pain, gram-positive cocci blood cultures, and positive tissue cultures for staphylococcus aureus may be consistent with the reported post-operative cellulitis and infection; however, the root cause of the reported clinical symptoms cannot be confirmed.The infection is highly likely of an exogenous nature and there is no evidence that our product contributed to the infection.It cannot be concluded that the post-operative infection is associated with a mal performance of the implant.The patient impact beyond the pain, irrigation and debridement procedures and post-op convalescence period cannot be determined.However, it has been noted that the patient has done extremely well.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.Based on the information provided we are unable to speculate on specific factors known to contribute to the alleged fault.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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