MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL; GII PS HI FLEX ISRT SZ 1-2 11

Model Number	71421502
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	04/11/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a knee replacement surgery was extended for one hour due to multiple attempts to steady lock the insert into the baseplate.A back-up insert was given which locked in successfully.
Additional Manufacturer Narrative
A correction based on new information received.

• Brand Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Common Device Name: GII PS HI FLEX ISRT SZ 1-2 11
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6547008
• Report Number: 1020279-2017-00318
• Device Sequence Number: 557756
• Product Code: JWH
• UDI-Device Identifier: 03596010492340
• UDI-Public: 03596010492340
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K032295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/16/2017

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: 06/02/2016
• Device Model Number: 71421502
• Device Catalogue Number: 71421502
• Device Lot Number: 16FM01862
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/11/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/05/2017
• Supplement Report FDA Received Date: 05/09/2017; 06/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 66 YR