MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CMT TIB SIZE 5 {} LEFT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71420168
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/07/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after two unsuccessful aspiration attempts due to pain and effusion, a knee arthroscopy was performed.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and details regarding the patient¿s weight-bearing status, bone quality, and other additional clinical relevant information have not been provided.Based on the limited information provided and without the return of the device for evaluation and diagnostic images, the root cause of the reported pain and loosening cannot be determined.However, the ongoing pain is likely due to the loosening of the component, and based on the patient medical records the patient sustained multiple falls in injuries following her implantation, these injuries cannot be ruled out as contributing factors for loosening of the components.(b)(4): although it was reported that the patient had a knee arthroscopy was performed on two different occasions no procedure documentation has been provided for review.It was also reported that the patient received several aspirations and without the results of the knee aspirations we are unable to rule out an infection as a contributory factor or the sutures which were removed in the second procedure.The patient impact beyond the procedures cannot be determined.No further clinical assessment is warranted at this time.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: GNS II CMT TIB SIZE 5 {} LEFT
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8348519
• Report Number: 1020279-2019-00650
• Device Sequence Number: 19409969
• Product Code: JWH
• UDI-Device Identifier: 03596010206275
• UDI-Public: 03596010206275
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/17/2026
• Device Catalogue Number: 71420168
• Device Lot Number: 16HM14076
• Initial Date Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 01/28/2019
• Initial Report FDA Received Date: 02/18/2019
• Supplement Report FDA Received Date: 06/17/2019
• 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: 59 YR