MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION PS OXIN FEM SZ6 RT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71421206
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Injury (2348); Joint Swelling (2356)
Date of Event	10/04/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an aspiration of fluid was required due to "sweeling".
Additional Manufacturer Narrative
The affected complaint devices were not returned for evaluation.A review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A clinical evaluation noted that based on the provided medical documentation, the root cause for the patient¿s revision is due to a loose tibial poly component of inadequate thickness and constraint.Aside from the patient¿s numerous falls, there does not appear to be a clinical cause for the patient¿s continued rt.Knee pain.Therefore, no further clinical assessment can be rendered at this time.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: LEGION PS OXIN FEM SZ6 RT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7985577
• Report Number: 1020279-2018-02237
• Device Sequence Number: 1395829
• Product Code: JWH
• UDI-Device Identifier: 00885556029138
• UDI-Public: 00885556029138
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K043440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2019

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: 71421206
• Device Lot Number: 14HM04641
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/04/2018
• Supplement Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 10/19/2018
• Supplement Report FDA Received Date: 03/04/2019
• 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: Other; Required Intervention