MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CMT TIB SIZE 5 {} LEFT; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED

Catalog Number	71420168
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/05/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the gii tibia was ex-planted during a revision surgery on august 5th.Item was left at the hospital and the surgeon is requesting an investigation as to the cause of why the tibia was loosened in the patient.
Additional Manufacturer Narrative
The associated device was returned and evaluated.The lab analysis concluded that there were signs of scratching, burnishing, and remnants of bone cement on the tibial baseplate.The scratching found on the tibial baseplate found during this investigation was likely caused by explantation.The burnishing on the articulating surface of the tibial baseplate was likely caused by contact with the tibial insert.The smooth surface found on the remaining bone cement could indicate that a layer of bone cement was removed possibly by using a surgical saw.The cause of the loosening originally stated in the complaint could not be determined by this investigation of the device.No evidence of material or manufacturing deviations were observed in this investigation.The medical investigation concluded that several attempts have been made to obtain clinical/medical documents to no avail.However, the component was returned for examination.The analysis did not reveal the root cause of the loosening.Without supporting clinical/medical documents, a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: GNS II CMT TIB SIZE 5 {} LEFT
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9109066
• Report Number: 1020279-2019-03460
• Device Sequence Number: 17041065
• Product Code: JWH
• UDI-Device Identifier: 03596010206275
• UDI-Public: 03596010206275
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2019

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 Catalogue Number: 71420168
• Device Lot Number: 17FM18296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2019
• Initial Date Received by Manufacturer: 08/26/2019
• Supplement Date Received by Manufacturer: 11/26/2019
• Initial Report FDA Received Date: 09/24/2019
• Supplement Report FDA Received Date: 12/03/2019
• 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