MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII LNG STEM 10MM X 100MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71420628
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/01/1901
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery, surgeon has had fractured tibia bones during two separate surgeries while implanting genesis ii 100 mm tibia stem.Further information is unknown yet.
Additional Manufacturer Narrative
The associated complaint device was not returned.A clinical evaluation was conducted and based on the limited information provided, the root cause of the reported tibial fractures during impaction cannot be definitively concluded.The patient impact beyond the intraoperative fracture with subsequent surgical extension and unanticipated fixation hardware and possible increased infection risk as well as additional radiological exposure cannot be determined.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.

• Brand Name: GII LNG STEM 10MM X 100MM
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8681313
• Report Number: 1020279-2019-02220
• Device Sequence Number: 14208422
• Product Code: JWH
• UDI-Device Identifier: 03596010208569
• UDI-Public: 03596010208569
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K953274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2019

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: 71420628
• Initial Date Received by Manufacturer: 05/16/2019
• Supplement Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 06/09/2019
• Supplement Report FDA Received Date: 10/25/2019
• 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