MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN CR HIGH FLEX XLPE SZ 5-6 9MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71453121
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/30/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was hospitalized due to a deep vein thrombosis.The event was resolved via medication.
Additional Manufacturer Narrative
The associated devices, used in treatment, were not returned, thus visual inspection could not be performed.A review of the device history records could not be performed due to no device batch information being provided.There is no evidence to suggest the devices failed to meet specifications.A complaint history review found related failures; this failure mode will be trended by post market surveillance to assess for any necessary corrective actions.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device to prevent future reoccurrence of the reported event.The medical investigation concluded that, without the requested clinical information, a thorough investigation cannot be rendered.However, since it was reported the patient's dvt was resolved with medication, no further clinical/medical assessment is warranted at this time.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.No further actions are being taken at this time.

• Brand Name: LGN CR HIGH FLEX XLPE SZ 5-6 9MM
• 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: 9253238
• Report Number: 1020279-2019-03784
• Device Sequence Number: 1724651
• Product Code: JWH
• UDI-Device Identifier: 00885556033982
• UDI-Public: 00885556033982
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2020

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: 71453121
• Initial Date Received by Manufacturer: 10/02/2019
• Supplement Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 10/29/2019
• Supplement Report FDA Received Date: 01/17/2020
• 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