MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II C/R FEM TR SZ 7 {} LEFT; PRSTHSIS,KNEE,PATLL/FEORTIBIL,SMICOSTRAIND,UNCMET OROUS,COTD,POLYMR/METL/POLYMR

Catalog Number	71430012
Medical Device Problem Codes	Mechanical Problem (1384); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/27/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported tha a revision surgery was done because the patient did not have adequate flexion of the knee post surgery.Initial surgery was approximately 3 years ago.The reason for revision was not related to implant malfunction.
Additional Manufacturer Narrative
The associated complaint device was not returned.A clinical evaluation was conducted and no clinical supporting documents were provided to conduct a thorough analysis of the reported issue. no medical assessment can be rendered.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 C/R FEM TR SZ 7 {} LEFT
• Common Device Name: PRSTHSIS,KNEE,PATLL/FEORTIBIL,SMICOSTRAIND,UNCMET OROUS,COTD,POLYMR/METL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7781185
• Report Number: 1020279-2018-01521
• Device Sequence Number: 1757863
• Product Code: MBH
• UDI-Device Identifier: 03596010211064
• UDI-Public: 03596010211064
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2018

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 Catalogue Number: 71430012
• Device Lot Number: ASKU
• Initial Date Received by Manufacturer: 07/27/2018
• Supplement Date Received by Manufacturer: 07/27/2018
• Initial Report FDA Received Date: 08/14/2018
• Supplement Report FDA Received Date: 10/05/2018
• 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