It was reported that after a thr performed on (b)(6) 2008, a revision surgery was performed on (b)(6) 2022 due to femoral neck fracture/ collapse of the resurfacing femoral head 46mm, possible loosening and removal of pseudo tumors.Surgical outcome was successful.No further information is available.
|
H3, h6: it was reported that a hip revision surgery was performed.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 and 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 similar complaints were identified to involve this batch.Other similar complaints have been identified for the part number and the reported failure mode.However, as bhr systems of this size are no longer sold, no action is to be taken.In the absence of the actual devices, the production records were reviewed for the known devices reportedly involved in this incident.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.All the 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.The =46mm bhr resurfacing system has been phased out from the market and as a result there is no live risk management file to review.Therefore, an evaluation of failure modes is not required.A review of historic escalation actions related to the products and similar complaint events was performed.Following the review, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible; no further escalation actions required.Smith and nephew has not received the explanted device and/or adequate materials to fully evaluate the complaint.If additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.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 limited 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.
|