MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION VALGUS GUIDE ASSEMBLY; PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY

Catalog Number 71434401

Device Problem Material Separation (1562)

Patient Problem Injury (2348)

Event Date 07/31/2019

Event Type  Injury  

Event Description

It was reported that during assembly of a revision surgery pin fell out.No injuries or delays reported.Backup device available.No more information provided yet.

Manufacturer Narrative

This complaint has been re-evaluated for mdr reporting.Therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: LEGION VALGUS GUIDE ASSEMBLY
• 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: 8929001
• MDR Text Key: 155477923
• Report Number: 1020279-2019-03160
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 03596010550071
• UDI-Public: 03596010550071
• Combination Product (y/n): N
• PMA/PMN Number: K121393
• 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: 10/03/2019

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 Catalogue Number: 71434401
• Device Lot Number: 06DM04521
• Initial Date Manufacturer Received: 07/31/2019
• Initial Date FDA Received: 08/26/2019
• Supplement Dates Manufacturer Received: 07/31/2019
• Supplement Dates FDA Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention