MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION PS NP FEM SZ 3 RT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71423233
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/02/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a right knee replacement surgery was performed at (b)(6) 2019.The patient found right knee joint pain at (b)(6) 2019 and it was found that fracture around the prosthesis.And a open reduction and internal fixation surgery was performed.Np more information provide yet.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, the x-rays provided demonstrate the fracture location in the distal femur anterior to the femoral component.Without the requested clinical information the root cause of the reported fracture cannot be confirmed.We cannot rule out non-compliance, bone quality, mental status, age, activity prior to full bone union as possible contributing factors to the reported fracture.The future impact to the patient beyond the fracture stabilization procedure cannot be determined.No further clinical/medical assessment is warranted at this time.Should any additional medical information be provided this complaint will be re-assessed.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.

• Brand Name: LEGION PS NP FEM SZ 3 RT
• 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: 8884487
• Report Number: 1020279-2019-03026
• Device Sequence Number: 11442070
• Product Code: JWH
• UDI-Device Identifier: 00885556030721
• UDI-Public: 00885556030721
• Combination Product (Y/N): N
• PMA/510(K) Number: K060742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2019

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 Expiration Date: 08/05/2018
• Device Catalogue Number: 71423233
• Device Lot Number: 18EM09140
• Initial Date Received by Manufacturer: 07/16/2019
• Supplement Date Received by Manufacturer: 07/16/2019
• Initial Report FDA Received Date: 08/12/2019
• Supplement Report FDA Received Date: 11/06/2019
• 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