MAUDE Adverse Event Report: SMITH & NEPHEW, INC. G2 CONST INSRT SZ1-2 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	OR71420960
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure of Implant (1924); Loss of Range of Motion (2032)
Date of Event	04/26/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent a revision surgery with exchange of tibial insert due to it being disengaged.Patient was presented to surgeon in (b)(6).With reduced range of motion and no other complications.X-ray showed the liner had disengaged.Review of x-rays one day post-op revealed the liner already disengaged then but had not been identified.All other components are satisfactory.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.Please see attached for the results of our investigation.

• Brand Name: G2 CONST INSRT SZ1-2 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6584354
• Report Number: 1020279-2017-00365
• Device Sequence Number: 10928321
• Product Code: JWH
• UDI-Device Identifier: 03596010210104
• UDI-Public: 03596010210104
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K962137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/28/2022
• Device Catalogue Number: OR71420960
• Device Lot Number: 12AM18678
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/26/2017
• Supplement Date Received by Manufacturer: 04/26/2017; 04/26/2017
• Initial Report FDA Received Date: 05/23/2017
• Supplement Report FDA Received Date: 10/03/2017; 10/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 75