MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CMT TIB SIZE 4 {} RIGHT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED.

Catalog Number	OR71420184
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/05/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that right knee revision surgery was performed due to loose tibia.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical medical team concluded, it was reported that a revision surgery was performed on the patient due to loosening of the tibia one year post implantation.Medial para patellar arthrotomy was performed.According to the operative report of the revision x-rays confirmed a loose tibia.No reports were submitted however for investigation purposes.No complications reported.Intraoperative finding of full thickness loss in all three compartments and severe spurring and bone on bone and the bone graft that was noted (from the primary report was most likely the root cause of the tibial loosening and subsequent revision; however, history previous multiple knee surgeries including acl repair and progressive djd cannot be ruled out as an additional potential contributing factor.The patient impact beyond the reported aseptic loosening and revision surgery cannot be determined.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed batches.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.

• Brand Name: GNS II CMT TIB SIZE 4 {} RIGHT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED.
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8488982
• Report Number: 1020279-2019-01396
• Device Sequence Number: 2689139
• Product Code: JWH
• UDI-Device Identifier: 03596010206343
• UDI-Public: 03596010206343
• 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 Implanted Year: 2013
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2019

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: 06/21/2023
• Device Catalogue Number: OR71420184
• Device Lot Number: 13ET31026
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/02/2019
• Supplement Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 10/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1