It was reported that, after a total left hip replacement was performed on (b)(6) 2016 the patient experienced an infection.For this reason, a revision surgery was performed on (b)(6) 2023, in which the acetlr cup hap 52mm w/ imptr, the spec ef prim ho 12/14 sz 3 and the modular head 46 mm -4 (short) were explanted.Patient's current health status is unknown.
|
H3, h6: it was reported that a left hip revision surgery was performed due to an infection.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.Without a definitive batch number, a complete review of the historical complaints data cannot be performed for the device.A review of historical complaints data was performed using the part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.No other similar complaints have been identified for any of the devices.This will continue to be monitored via routine trending, however it should be noted that these devices are no longer sold.As no device batch numbers were provided for investigation, manufacturing record review could not be performed.If more information is received, this investigation will be reopened.The review of the most recent 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.Although, it is noted the revision was done due to infection, as of the date of this medical investigation, the requested clinical documentation has not been provided.Therefore, the clinical root cause of the infection and subsequent revision could not be confirmed.The patient impact beyond the reported revision cannot be determined.Based on the information provided, further investigation of the reported complaint cannot be carried out and remains inconclusive.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.
|