SMITH & NEPHEW, INC. HIP IMPLANT; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
|
Back to Search Results |
|
Device Problem
Insufficient Information (3190)
|
Patient Problem
Injury (2348)
|
Event Type
Injury
|
Event Description
|
In a scientific publication, author: zhang junhui et all., "analysis on the short-term and medium-term efficacy of aseptic prosthesis loosening and revision after application of extensive porous coating stem in the primary hip joint replacement" it was reported that the patient underwent debridement and suturing due to incision exudation and subcutaneous hematoma.The patient was implanted with an echelon stem and it is unknown which other devices the patient had implanted.
|
|
Manufacturer Narrative
|
It was reported from a literature review that the patient underwent debridement and suturing due to incision exudation and subcutaneous hematoma.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As device information was not made available, device history record and complaint history review cannot be completed.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Some potential causes of the reported event could include but are not limited to patient reaction or and post-operative healing issue.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.
|
|
Search Alerts/Recalls
|
|
|