SMITH & NEPHEW, INC. UNKN R3 SHELL; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
|
Back to Search Results |
|
Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Unequal Limb Length (4534)
|
Event Date 11/06/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
Internal complaint reference: (b)(4).Wade, r., & shah, k.A.(2020).Functional and radiological outcome of uncemented total hip arthroplasty in young adults-5 year follow-up.Journal of orthopaedics, 18, 237-239.Doi: https://doi.Org/10.1016/j.Jor.2019.10.014.
|
|
Event Description
|
It was reported that on literature review "functional and radiological outcome of uncemented total hip arthroplasty in young adults - 5 year follow-up", three (3) patients had more than 2 cm limb lengthening after a primary uncemented tha.It was not reported how the adverse event was resolved.The outcome of the patient is unknown.No further information is available.
|
|
Manufacturer Narrative
|
H3, h6: the devices were not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per case details, in a literature review, ""functional and radiological outcome of uncemented total hip arthroplasty in young adults - 5 year follow-upollow-up", three (3) patients had more than 2 cm limb lengthening after a primary uncemented tha.Patients outcomes, current health status and how the event was managed was not provided.It has been communicated per case details that no additional information is available.Smith and nephew has not received the requested patient specific documentation, or adequate materials to fully evaluate the root cause of the complaint.Patient impact beyond that which was reported could not be determined.If additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to procedural/user error, surgical complication or patient condition.The contribution of the devices to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual products involved, our investigation could not proceed.Should the devices or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
|
|
Search Alerts/Recalls
|
|
|