MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION HINGE FEM TRL SZ 5 LT; PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY

Catalog Number 71434173

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/11/2019

Event Type  malfunction  

Event Description

It was reported that during procedure the 2mm offset coupler is stuck in the 5l hinge femoral trial.No injuries or delays reported.Back up available.

Manufacturer Narrative

The associated devices were returned and evaluated.A visual inspection of the returned devices confirmed the stated failure mode.The lock screw was missing from the coupler trial, which would not allow it to be removed from the femoral trial.The devices were manufactured in 2008 and 2012 and exhibit signs of extensive wear/usage.A review of complaint history did not reveal additional complaints for the listed batches for the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: LEGION HINGE FEM TRL SZ 5 LT
• Type of Device: PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8592015
• MDR Text Key: 144453591
• Report Number: 1020279-2019-01816
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00885556032664
• UDI-Public: 00885556032664
• Combination Product (y/n): N
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71434173
• Device Lot Number: 12MPG0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2019
• Date Manufacturer Received: 04/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1