MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CON INS SZ7-8 18MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71420558
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	03/26/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that incision, debridement and placement wound were performed.It was found to have approximately a 4cm dehiscence of the very inferior portion of the wound.There was a concern that the patellar tendon may well be exposed.
Additional Manufacturer Narrative
The associated complaint device was not returned.A clinical evaluation was conducted and based on the information provided, the only product failure, noted in the long list of unfortunate events, was for the 2nd revision on 3-6-2018.The procedure notes documented ¿mechanical complications of device with failure of fixation mechanism ¿ arthrofibrosis with severe range of motion limitation ¿ failure of the anterior locking component of the tibial poly insert and tibial base plate.The root cause of this failure cannot be concluded, however the documented arthrofibrosis cannot be excluded as a contributing factor.No current or updated information regarding the patient¿s current status has been provided at this time.A review of complaint history on the listed part revealed no prior complaints for the listed batch 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 CON INS SZ7-8 18MM
• 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: 7924140
• Report Number: 1020279-2018-02020
• Device Sequence Number: 1639850
• Product Code: JWH
• UDI-Device Identifier: 03596010208217
• UDI-Public: 03596010208217
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2018

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: 07/25/2022
• Device Catalogue Number: 71420558
• Device Lot Number: 12GM15080
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 10/01/2018
• Supplement Report FDA Received Date: 12/17/2018
• 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