MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION HINGE 18MM BOLT; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 71421689

Device Problem Insufficient Information (3190)

Patient Problem Joint Dislocation (2374)

Event Date 05/29/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to dislocation.The insert, the bolt and the sleeve were exchanged.

Manufacturer Narrative

The associated legion hinge guided motion insert, post bolt, post sleeve were returned and evaluated.A lab analysis conducted during this investigation noted that the insert showed slight wear or possible polishing on the superior surface.The post bolt showed slight scratches on the unthreaded length of the shaft.The post sleeve showed light scratches on the smaller outer diameter length and taper of the device.The post sleeve did not appear to be broken when inspected visually.The exact cause of observed scratches and wear could not be determined from the investigation of the device.There were no observations of material or manufacturing deviations in the course of this investigation.A clinical evaluation was performed and noted that the reported sleeve breakage cannot be confirmed based on information provided.The causal relationship of the reported dislocation of the ¿fem/tib¿ with the legion components cannot be confirmed, however, the reported ¿noted possible technique flaw with initial sleeve insertion¿ is most likely the contributing factor to the reported event.The patient impact beyond the reported revision and dislocated ¿fem/tib¿ and expected post-operative rehabilitation period cannot be determined.No further medical assessment is warranted at this time.A review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: LEGION HINGE 18MM BOLT
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7608277
• MDR Text Key: 111294235
• Report Number: 1020279-2018-01135
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 71421689
• Device Lot Number: 12JTM0012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Initial Date Manufacturer Received: 05/29/2018
• Initial Date FDA Received: 06/16/2018
• Supplement Dates Manufacturer Received: 05/29/2018
• Supplement Dates FDA Received: 01/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention