MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN TIB PLY OLAY MAG LM/RL 9MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 71243609

Device Problems Fracture (1260); Cut In Material (2454)

Patient Problems No Information (3190); No Code Available (3191)

Event Date 12/12/2017

Event Type  Injury  

Event Description

It was reported that an acuris prothesis was fitted on the patient on (b)(6) 2016.The post surgery xray on (b)(6) 2016 was normal but during a check up visit on (b)(6) 2017 it was discovered that the tibial plate wire was cut.A scan was performed on (b)(6) 2018 to plan a revision.

Manufacturer Narrative

The associated complaint device was not returned for evaluation.[(b)(4)].

• Brand Name: GEN TIB PLY OLAY MAG LM/RL 9MM
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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 ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 7207989
• MDR Text Key: 97850861
• Report Number: 1020279-2018-00073
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 03596010501707
• UDI-Public: 03596010501707
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K912735
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/04/2024
• Device Catalogue Number: 71243609
• Device Lot Number: 14DM05702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/07/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention