MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION HINGE TIBIAL STABILIZING TOOL; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number 71434465

Device Problems Break (1069); Fracture (1260); Difficult to Remove (1528)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 02/07/2017

Event Type  malfunction  

Event Description

The tibial stabilising tool broke which left the peg from the tool loaded in the tibial baseplate.This peg was extremely hard to remove and took about 5 mins to take out.In case of re-occurrence the peg potentially might become stuck in implant and remains in patient.

• Brand Name: LEGION HINGE TIBIAL STABILIZING TOOL
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: markus poettker ; schachenallee 29; aarau 5001 ; SZ 5001 ; 0628320660
• MDR Report Key: 6338941
• MDR Text Key: 67959718
• Report Number: 1020279-2017-00108
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71434465
• Device Catalogue Number: 71434465
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1