MAUDE Adverse Event Report: SMITH AND NEPHEW, INC. GNS II RESURF PAT 29MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71420574
Health Effect - Clinical Code	Fibrosis (3167)
Date of Event	04/12/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a right knee manipulation was performed due to arthrofibrosis status post recent polyethylene exchange.
Additional Manufacturer Narrative
It was reported that a right knee manipulation was performed due to arthrofibrosis post revision surgery.The associated journey ii bcs cobalt chrome femoral component, journey ii bcs articular insert, genesis ii resurfacing patellar component and genesis ii cemented tibial baseplate, used in treatment, were not returned for evaluation.Thus the product analysis could not be performed.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.Our investigation including a review of the manufacturing records for the reported batches, except for the insert, did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident could not be corroborated.A review of instructions for use revealed the alleged failure is previously identified in the possible adverse events.A clinical analysis noted that based on the available information, the revision of the insert was required because of the miss-match as stated in the documentation.The ¿manipulation under anesthesia¿ was required secondary to arthrofibrosis.The root cause of the arthrofibrosis cannot be specifically concluded; however it is a common complication of surgery.Three weeks post procedure, the patient is ¿doing well ¿ no complaints¿.Per our risk assessment, probable cause could include but not limited to surgical complication.Without the return of the actual products involved, our investigation of this report is inconclusive.Based on this investigation, the need for corrective action is not indicated.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: GNS II RESURF PAT 29MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH AND NEPHEW, INC.; 1450 brooks road; memphis, tennessee; memphis 38116
• MDR Report Key: 7931736
• Report Number: 1020279-2018-02098
• Device Sequence Number: 19316837
• Product Code: JWH
• UDI-Device Identifier: 03596010208293
• UDI-Public: 03596010208293
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/05/2020

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: 09/20/2026
• Device Model Number: 71420574
• Device Catalogue Number: 71420574
• Device Lot Number: 16JM11766
• Initial Date Received by Manufacturer: 09/10/2018
• Supplement Date Received by Manufacturer: 09/10/2018; 01/30/2020
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 12/05/2018; 02/05/2020
• 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: Other; Required Intervention